PROCRIT^® (Epoetin alfa) is approved for the treatment of:

Anemia Due to Chronic Kidney Disease:

PROCRIT^® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

Anemia Due to Zidovudine in HIV-infected Patients:

PROCRIT^® is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

Anemia Due to Chemotherapy in Patients With Cancer:

PROCRIT^® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery:

PROCRIT^® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT^® is not indicated for patients who are willing to donate autologous blood preoperatively.

PROCRIT^® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT^® is not indicated for use:

• In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
• In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• In patients scheduled for surgery who are willing to donate autologous blood.
• In patients undergoing cardiac or vascular surgery.
• As a substitute for RBC transfusions in patients who require immediate correction of anemia.

Click to learn more at PROCRIT.com
Click to view the Important Safety Information
Click to view the full Prescribing Information, including Boxed WARNING
Click to view the Medication Guide for Patients
Click to view the Patient Instructions for use

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PROCRIT^® (epoetin alfa)?

Using PROCRIT^® can lead to death or other serious side effects.

For patients with Cancer:

Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe PROCRIT^®. Before you can begin to receive PROCRIT^®, you must sign the patient-healthcare provider acknowledgment form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking PROCRIT^®.

These risks include that your tumor may grow faster and you may die sooner if you choose to take PROCRIT^®.

You should talk with your healthcare provider about:

• Why PROCRIT^® treatment is being prescribed for you.
• What are the chances you will get red blood cell transfusions if you do not take PROCRIT^®.
• What are the chances you will get red blood cell transfusions even if you take PROCRIT^®.
• How taking PROCRIT^® may affect the success of your cancer treatment.

After you have finished your chemotherapy course, PROCRIT^® treatment should be stopped.

For all patients who take PROCRIT^®, including patients with cancer or chronic kidney disease:

• If you decide to take PROCRIT^®, your healthcare provider should prescribe the smallest dose of PROCRIT^® that is needed to reduce your chance of getting red blood cell transfusions.
• You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with PROCRIT^® to reach a normal or near-normal hemoglobin level.
• You may get blood clots at any time while taking PROCRIT^®. If you are receiving PROCRIT^® for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you will need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).

Call your healthcare provider or get medical help right away if you have any of these symptoms of blood clots:

• Chest pain
• Trouble breathing or shortness of breath
• Pain in your legs, with or without swelling
• A cool or pale arm or leg
• Sudden confusion, trouble speaking, or trouble understanding others’ speech
• Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
• Sudden trouble seeing
• Sudden trouble walking, dizziness, loss of balance or coordination
• Loss of consciousness (fainting)
• Hemodialysis vascular access stops working

Who should not take PROCRIT^®?

Do not take PROCRIT^® if you:

• Have cancer and have not been counseled by your healthcare provider regarding the risks of PROCRIT^® or if you have not signed the patient-healthcare provider acknowledgment form before you start PROCRIT^® treatment.
• Have high blood pressure that is not controlled (uncontrolled hypertension).
• Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with PROCRIT^® or other erythropoietin protein medicines.
• Have had a serious allergic reaction to PROCRIT^®.

Do not give PROCRIT^® from multi-dose vials to:

• Pregnant or breastfeeding women
• Babies

What should I tell my healthcare provider before taking PROCRIT^®?

PROCRIT^® may not be right for you. Tell your healthcare provider about all your health conditions, including if you:

• Have heart disease.
• Have high blood pressure.
• Have had a seizure (convulsion) or stroke.
• Have any other medical conditions.
• Are pregnant or planning to become pregnant. It is not known if PROCRIT^® may harm your unborn baby. Talk with your healthcare provider about possible pregnancy and birth control choices that are right for you.
• Are breast-feeding or planning to breast-feed. It is not known if PROCRIT^® passes into breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

What are the possible side effects of PROCRIT^®?

PROCRIT^® may cause serious side effects.

• See "What is the most important information I should know about PROCRIT^®?"
• High blood pressure. High blood pressure is a common side effect of PROCRIT^® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking PROCRIT^®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
• Seizures. If you have any seizures while taking PROCRIT^®, get medical help right away and tell your healthcare provider.
• Antibodies to PROCRIT^®. Your body may make antibodies to PROCRIT^®. These antibodies can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking PROCRIT^®.
• Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using PROCRIT^® and call your healthcare provider or get medical help right away.
• Dangers of giving PROCRIT^® to newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT^® from multi-dose vials in newborns, infants, pregnant or breastfeeding women because the PROCRIT^® in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. PROCRIT^® that comes in single-dose vials does not contain benzyl alcohol. See "Who should not take PROCRIT^®?".

Common side effects of PROCRIT^® include:

• Joint, muscle, or bone pain
• Fever
• Cough
• Rash
• Nausea
• Vomiting
• Soreness of mouth
• Itching
• Headache
• Redness and pain in the skin where PROCRIT^® shots were given

These are not all of the possible side effects of PROCRIT^®. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.

Please read the Medication Guide and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

ReoPro^® (abciximab) is indicated as an adjunct to percutaneous coronary intervention (PCI) for the prevention of cardiac ischemic complications:

• In patients undergoing PCI
• In patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours

Safety and efficacy of ReoPro^® use in patients not undergoing PCI have not been established. ReoPro^® is intended for use with aspirin and heparin and has been studied only in that setting, as described in clinical studies.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• Active internal bleeding
• Recent (within 6 weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
• History of cerebrovascular accident (CVA) within 2 years, or CVA with a significant residual neurological deficit
• Bleeding diathesis
• Administration of oral anticoagulants within 7 days unless prothrombin time ≤1.2 times control
• Thrombocytopenia (<100,000 cells/µL)
• Recent (within 6 weeks) major surgery or trauma
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• Severe uncontrolled hypertension
• Presumed or documented history of vasculitis
• Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention
• Known hypersensitivity to any component of this product or to murine proteins

WARNINGS

Bleeding Risk

ReoPro^® has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation agents, for example, from heparin or other anticoagulants. The risk of a major bleed due to ReoPro^® therapy is increased in patients receiving thrombolytics and should be weighed against the anticipated benefits. In the EPILOG and EPISTENT trials, the incidence of major bleeding in patients receiving ReoPro^® and low-dose heparin was similar to placebo levels.

ALLERGIC REACTIONS (including anaphylaxis)

Allergic reactions, some of which were anaphylaxis (sometimes fatal), have been reported rarely in patients treated with ReoPro^®. Patients with allergic reactions should receive appropriate treatment. Treatment of anaphylaxis should include immediate discontinuation of ReoPro^® administration and initiation of resuscitative measures.

PRECAUTIONS

Thrombocytopenia

In clinical trials, patients treated with ReoPro^® were more likely than patients who received placebo to experience decreases in platelet counts (also see Readministration).

Modestly lower rates were observed among patients treated with placebo plus standard-dose heparin.

Readministration of ReoPro^®

Administration of ReoPro^® may result in the formation of human anti-chimeric antibodies (HACA) that could potentially cause allergic or hypersensitivity reactions (including anaphylaxis), thrombocytopenia, or diminished benefit upon readministration. In a registry study of ReoPro^® readministration (1342 treatments in 1286 patients), there were no reports of serious allergic reactions or anaphylaxis. Thrombocytopenia was observed at higher rates in the readministration study than in the phase 3 studies of first-time administration, suggesting that readministration may be associated with an increased incidence and severity of thrombocytopenia. This increased risk was associated with a history of thrombocytopenia on prior ReoPro^® exposure, a positive HACA assay at baseline, and readministration within 30 days.

Guidelines for Reduction in Bleeding

• Use of a low-dose, weight-adjusted heparin regimen
• Discontinuation of heparin on completion of the procedure with removal of the arterial sheath within 6 hours
• Careful vascular access site management and careful patient management, including attention to other potential bleeding sites
• Use of a weight-adjusted bolus and continuous infusion dose of ReoPro^® measures should be initiated

DOSAGE & ADMINISTRATION

The safety and efficacy of ReoPro^® have only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL STUDIES. Please see the full prescribing information for detailed information.

As an adjunct to PCI:

ReoPro^® (abciximab) intravenous bolus plus infusion

• - IV bolus 0.25 mg/kg 10 to 60 minutes before PCI followed by
• - IV infusion 0.125 mcg/kg/minute (max of 10 mcg/minute) for 12 hours

Onset and Reversibility

Onset The onset of ReoPro^® following a 0.25 mg/kg bolus dose (plus 0.125 mcg/kg/minute infusion) is rapid with the inhibitory effects evident within 10 minutes. Low levels of GP IIb/IIIa receptor blockade are present for more than 10 days following cessation of the infusion.

Reversibility Upon discontinuation of therapy with ReoPro^®, bleeding time returns to less than or equal to 12 minutes within 12 hours. Inhibitory effects of ReoPro^® can be rapidly reversed, at least in part, with platelet transfusions.

For additional safety information, please consult the Important Safety Information or the Prescribing Information for ReoPro^®.

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Click here for DOXIL^® supply updates.

INDICATIONS

DOXIL^® (doxorubicin HCl liposome injection) is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

DOXIL^® is used with VELCADE^® (bortezomib) for Injection to treat patients with multiple myeloma who have received at least one prior therapy (other than VELCADE^®).

DOXIL^® is administered intravenously by your healthcare professional.

Click to learn more at DOXIL.com
Click to view Important Safety Information
Click to view the Full Prescribing Information, including Boxed WARNINGS

IMPORTANT SAFETY INFORMATION

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL^®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

DOXIL^® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health. Your doctor will monitor your blood laboratory results.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.

If you are pregnant, planning to become pregnant, or nursing inform your doctor. Nursing should be discontinued during treatment with DOXIL^®.

You should not take DOXIL^® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

The most common side effects reported in at least 20% of patients treated with DOXIL during clinical studies were: weakness, fever, nausea, vomiting, stomatitis (painful redness, swelling, or sores in the mouth), diarrhea, and rash, loss of appetite, low white blood cell count, low platelet count, anemia, tiredness, and constipation. Hand-foot syndrome, which may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet, was reported as well. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in > 40% of patients.

Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL^® may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL^® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL^® and will go away as the drug leaves the body.

Your doctor may prescribe anti nausea medications before or during your DOXIL^® treatment.

Please talk to your doctor or nurse if you have any additional questions regarding DOXIL^®.

For more information about DOXIL^® therapy, please visit www.DOXIL.com.

Please see full Product Information for more details.

VELCADE^® is a registered trademark of Millennium Pharmaceuticals, Inc.

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Click here for DOXIL^® supply updates.

INDICATIONS

DOXIL^® (doxorubicin HCl liposome injection) is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

DOXIL^® is used with VELCADE^® (bortezomib) for Injection to treat patients with multiple myeloma who have received at least one prior therapy (other than VELCADE^®).

DOXIL^® is administered intravenously by your healthcare professional.

Click to learn more at DOXIL.com
Click to view Important Safety Information
Click to view the Full Prescribing Information, including Boxed WARNINGS

IMPORTANT SAFETY INFORMATION

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL^®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

DOXIL^® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health. Your doctor will monitor your blood laboratory results.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.

If you are pregnant, planning to become pregnant, or nursing inform your doctor. Nursing should be discontinued during treatment with DOXIL^®.

You should not take DOXIL^® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

The most common side effects reported in at least 20% of patients treated with DOXIL during clinical studies were: weakness, fever, nausea, vomiting, stomatitis (painful redness, swelling, or sores in the mouth), diarrhea, and rash, loss of appetite, low white blood cell count, low platelet count, anemia, tiredness, and constipation. Hand-foot syndrome, which may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet, was reported as well. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in > 40% of patients.

Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL^® may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL^® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL^® and will go away as the drug leaves the body.

Your doctor may prescribe anti nausea medications before or during your DOXIL^® treatment.

Please talk to your doctor or nurse if you have any additional questions regarding DOXIL^®.

For more information about DOXIL^® therapy, please visit www.DOXIL.com.

Please see full Product Information for more details.

VELCADE^® is a registered trademark of Millennium Pharmaceuticals, Inc.

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REMICADE^® (infliximab) is for patients with:

Plaque Psoriasis

REMICADE^® is approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if REMICADE^® is appropriate considering other available therapies.

Rheumatoid Arthritis

REMICADE^®, used in combination with methotrexate, can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active RA.

Psoriatic Arthritis

REMICADE^® can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis.

Crohn's Disease

REMICADE^® can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who haven't responded well to other therapies.

Pediatric Crohn's Disease

REMICADE^® can reduce signs and symptoms and induce and maintain remission in children (6 years and older) with moderately to severely active Crohn's disease who haven't responded well to other therapies.

Ankylosing Spondylitis

REMICADE^® can reduce signs and symptoms in patients with active ankylosing spondylitis.

Ulcerative Colitis

REMICADE^® can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in patients with moderately to severely active UC who haven't responded well to other therapies.

Pediatric Ulcerative Colitis

REMICADE^® can reduce signs and symptoms and induce and maintain remission in children (6 years and older) with moderately to severely active ulcerative colitis who haven't responded well to other therapies.

Click to learn more at REMICADE.com
Click to view the Important Safety Information
Click to view the full Prescribing Information, including Boxed Warnings
Click to view the Medication Guide for Patients

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

• Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
• Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
• Infections that keep coming back, have diabetes or an immune system problem.
• Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
• Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
• Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
• Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor if you:

• Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE^®.
• Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using REMICADE^® during your pregnancy. Tell your baby’s doctor about your REMICADE^® use before the baby receives any vaccine because of an increased risk of infection for up to 6 months after your last dose of REMICADE^® you received during your pregnancy.

Adults and children should not receive a live vaccine while taking REMICADE^®.

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.

You should tell your doctor right away if you have any of the signs listed below:

• Infections (like TB, blood infections, pneumonia)-fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
• Lymphoma, or any other cancers in adults and children.
• Skin cancer-any changes in or growths on your skin.
• Heart failure-new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
• Reactivation of HBV-feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
• Liver injury-jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
• Blood disorders-fever that doesn't go away, bruising, bleeding or severe paleness.
• Nervous system disorders-numbness, weakness, tingling, changes in your vision or seizures.
• Allergic reactions during or after the infusion-hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
• Lupus-like syndrome-chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
• Psoriasis-new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Please read the Medication Guide for REMICADE^® and discuss it with your doctor. (Requires Adobe Acrobat Reader. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Click here for DOXIL^® supply updates.

INDICATIONS

DOXIL^® (doxorubicin HCl liposome injection) is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

DOXIL^® is used with VELCADE^® (bortezomib) for Injection to treat patients with multiple myeloma who have received at least one prior therapy (other than VELCADE^®).

DOXIL^® is administered intravenously by your healthcare professional.

Click to learn more at DOXIL.com
Click to view Important Safety Information
Click to view the Full Prescribing Information, including Boxed WARNINGS

IMPORTANT SAFETY INFORMATION

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL^®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

DOXIL^® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health. Your doctor will monitor your blood laboratory results.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.

If you are pregnant, planning to become pregnant, or nursing inform your doctor. Nursing should be discontinued during treatment with DOXIL^®.

You should not take DOXIL^® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

The most common side effects reported in at least 20% of patients treated with DOXIL during clinical studies were: weakness, fever, nausea, vomiting, stomatitis (painful redness, swelling, or sores in the mouth), diarrhea, and rash, loss of appetite, low white blood cell count, low platelet count, anemia, tiredness, and constipation. Hand-foot syndrome, which may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet, was reported as well. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in > 40% of patients.

Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL^® may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL^® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL^® and will go away as the drug leaves the body.

Your doctor may prescribe anti nausea medications before or during your DOXIL^® treatment.

Please talk to your doctor or nurse if you have any additional questions regarding DOXIL^®.

For more information about DOXIL^® therapy, please visit www.DOXIL.com.

Please see full Product Information for more details.

VELCADE^® is a registered trademark of Millennium Pharmaceuticals, Inc.

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SIMPONI^® is used in adults with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is neccessary to continue taking steroid medicines:

• to begin helping some of your symptoms
• in people who respond to SIMPONI^®, to get their UC under control (induce remission) and keep UC under control (sustain remission)
• to begin to improve the way the lining of your large intestine looks to your doctor during colonoscopy

 

SIMPONI^® is a self-injectable biologic treatment given every 4 weeks after 2 starter doses.

SIMPONI^® (golimumab) is a once-monthly self-injectable biologic treatment for adults with:

• moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate
• active psoriatic arthritis, alone or with the medicine methotrexate
• active ankylosing spondylitis

Methotrexate is used as directed

Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI^® under the skin, just once a month.

Click to learn more at SIMPONI.com
Click to view the Important Safety Information
Click to view the Full Prescribing Information
Click to view the Medication Guide for Patients

IMPORTANT SAFETY INFORMATION

SIMPONI^® (golimumab) is a prescription medicine. SIMPONI^® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI^® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI^® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

• fever, sweat, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more than normal
• feel very tired

 

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI^®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI^® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI^®, tell your doctor.

Tell your doctor about all the medications you take including ORENCIA^® (abatacept), KINERET^® (anakinra), ACTEMRA^® (tocilizumab), RITUXAN^® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI^® should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI^®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI^®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• skin rash

 

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI^®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blockers, including SIMPONI^®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Serious liver problems can happen in people using TNF blockers, including SIMPONI^®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI^®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI^® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI^® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI^® include: upper respiratory tract infection, reaction at site of injection, and viral infections.

Please read the Medication Guide for SIMPONI^® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

STELARA^® (ustekinumab) is a prescription medicine approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

Click to learn more at STELARAinfo.com
Click to view the Important Safety Information
Click to view the full Prescribing Information
Click to view the Medication Guide for Patients

IMPORTANT SAFETY INFORMATION

STELARA^® is a prescription medicine that affects your immune system. STELARA^® can increase your chance of having serious side effects including:

Serious Infections

STELARA^® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA^®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your doctor should check you for TB before starting STELARA^® and watch you closely for signs and symptoms of TB during treatment with STELARA^®.
• If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA^®.

You should not start taking STELARA^® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA , tell your doctor if you think you have an infection or have symptoms of an infection such as:

• fever, sweats, or chills
• muscle aches
• cough
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more often than normal
• feel very tired
• shortness of breath
• blood in your phlegm
• weight loss
• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have TB, or have been in close contact with someone who has TB

After starting STELARA , call your doctor right away if you have any symptoms of an infection (see above).

STELARA^® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA^® will get any of these infections because of the effects of STELARA^® on these proteins.

Cancer

STELARA^® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA^®. Tell your doctor if you have new skin growths.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.

Before receiving STELARA^®, tell your doctor if you:

• have any of the conditions or symptoms listed above for serious infections, cancer, or RPLS
• have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA^® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA^® or one year after you stop taking STELARA^®. Non-live vaccinations received while taking STELARA^® may not fully protect you from disease.
• are receiving or have received allergy shots, especially for serious allergic reactions
• ever had an allergic reaction to STELARA^®
• receive or have received phototherapy for your psoriasis
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if STELARA^® will harm your unborn baby. You and your doctor should decide if you will take STELARA^®.
• are breast-feeding or plan to breast-feed. It is thought that STELARA^® passes into your breast milk. You should not breast-feed while taking STELARA^® without first talking to your doctor.

Tell your doctor about all the medicines you take,

including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that affect your immune system
• certain medicines that can affect how your liver breaks down other medicines

Common side effects of STELARA^® include: upper respiratory infections, headache, and tiredness.

These are not all of the side effects with STELARA^®. Tell your doctor about any side effect that bothers you or does not go away. Ask your doctor or pharmacist for more information.

Please read the Medication Guide and full Prescribing Information for STELARA^® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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ZYTIGA^® (abiraterone acetate)

Indication

What is Zytiga^®?

ZYTIGA^® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA^® is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body.

Click to learn more at ZYTIGA.com
Click to view the Important Safety Information
Click to view the full Prescribing Information

IMPORTANT SAFETY INFORMATION

Who should not take ZYTIGA^® (abiraterone acetate)?

Do not take ZYTIGA^® if you are pregnant or may become pregnant. ZYTIGA^® may harm your unborn baby. Women who are pregnant or who may become pregnant should not touch ZYTIGA^® without protection, such as gloves.

ZYTIGA^® is not for use in women or children. Keep ZYTIGA^® and all medicines out of the reach of children.

Before you take ZYTIGA^®, tell your healthcare provider if you:

• Have heart problems
• Have liver problems
• Have a history of adrenal problems
• Have a history of pituitary problems
• Have any other medical conditions
• Plan to become pregnant (See “Who should not take ZYTIGA^®?”)
• Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA^® passes into your breast milk. You and your healthcare provider should decide if you will take ZYTIGA^® or breastfeed. You should not do both. (See “Who should not take ZYTIGA^®?”)
• Take any other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYTIGA^® can interact with many other medicines.

If you are taking ZYTIGA^®:

• Take ZYTIGA^® and prednisone exactly as your healthcare provider tells you.
• Take your prescribed dose of ZYTIGA^® one time a day. Your healthcare provider may change your dose if needed.
• Do not stop taking your prescribed dose of ZYTIGA^® or prednisone without talking to your healthcare provider first.
• Take ZYTIGA^® on an empty stomach. Do not take ZYTIGA^® with food. Taking ZYTIGA^® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
• No food should be eaten 2 hours before and 1 hour after taking ZYTIGA^®.
• Swallow ZYTIGA^® tablets whole. Do not crush or chew tablets.
• Take ZYTIGA^® tablets with water.
• Your healthcare provider will do blood tests to check for side effects.
• Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with ZYTIGA^®. If their sexual partner may become pregnant a condom and another form of birth control must be used during and for one week after treatment with ZYTIGA^®. Talk with your healthcare provider if you have any questions about birth control.

ZYTIGA^® may cause serious side effects including:

• High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema).
• Tell your healthcare provider if you get any of the following symptoms:
  • Dizziness
  • Fast heartbeats
  • Feel faint or lightheaded
  • Headache
  • Confusion
  • Muscle weakness
  • Pain in your legs
  • Swelling in your legs or feet
• Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.
• Liver problems. You may develop changes in liver function blood test. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA^® and during treatment with ZYTIGA^®.
• The most common side effects of ZYTIGA^® include:
  • Weakness
  • Joint swelling or pain
  • Swelling in your legs or feet
  • Hot flushes
  • Diarrhea
  • Vomiting
  • Cough
  • High blood pressure
  • Shortness of breath
  • Urinary tract infection
  • Bruising
  • Low red blood cells (anemia) and low blood potassium levels
  • High blood sugar levels, high blood cholesterol and triglycerides
  • Certain other abnormal blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA^®.

FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

ZYTIGA^® can interact with other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA^®.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

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