Oncology Products

DOXIL^®(doxorubicin HCl liposome injection)

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May 9, 2012 update.

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Recurrent Ovarian Cancer

DOXIL^®(doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy.

Relapsed or Refractory Multiple Myeloma

DOXIL^® in combination with VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy.

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

BOXED WARNINGS
Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution

• The use of DOXIL^® may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2
  • Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose
  • Cardiac toxicity may also occur at lower cumulative doses (400 mg/m2) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy
• Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL^®. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate
  • Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
  • The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions
• Severe myelosuppression may occur
• DOXIL^® dosage should be reduced in patients with impaired hepatic function
• Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis

Contraindications

• Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL^®
• Nursing mothers

Additional Safety Information

• Cardiac function should be carefully monitored
  • Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy
  • For patients with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury
  • In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus DOXIL^® arm experienced left ventricular ejection fraction decrease (defined as absolute decrease ≥15% over baseline or a ≥5% decrease below institutional lower limit of normal)
• Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL^®
  • In patients with recurrent ovarian cancer or AIDS-related Kaposi's sarcoma, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL^®
  • In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL^® and/or VELCADE
  • Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage
  • Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death
• DOXIL^® may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow
• Hand-foot syndrome (HFS) may occur during therapy with DOXIL^®
  • Based on HFS toxicity grade, dose reduction, delay in administration, or discontinuation of DOXIL^® may be required
  • HFS was generally observed after 2 to 3 cycles of treatment, but may occur earlier
    • The reaction was mild in most patients, resolving in 1 to 2 weeks
    • The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy
• DOXIL^® is an irritant, not a vesicant; use precautions to avoid extravasation
• DOXIL^® can cause fetal harm when used during pregnancy
• Recall reaction has occurred with DOXIL^® administration after radiotherapy
• DOXIL^® may interact with drugs known to interact with the conventional formulation of doxorubicin HCl
• In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) ≥20% (DOXIL^® vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)
  • In addition, 19% vs 52.3% reported alopecia (all grades)
  • Grade 3/4 hematologic ARs reported in ≥5% (DOXIL^® vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)
• In patients with multiple myeloma, the most common all-grade ARs ≥20%
  (VELCADE plus DOXIL^® vs VELCADE, respectively) included: neutropenia (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31% vs 31%), mucositis/stomatitis (20% vs 5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%)
  • In addition, 19% vs <1% reported HFS

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.

Please see Full Product Information in PDF format, for more details.

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PROCRIT^®(Epoetin alfa)

Important safety update, including boxed warning. Please read more

Product alert: Voluntary product recall notice. Please read more.

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.

• PROCRIT^® use has not been shown to improve quality of life, fatigue, or patient well-being.
• PROCRIT^® is not indicated for use in patients receiving hormonal agents, biologic products, or radiotherapy unless also receiving concomitant myelosuppressive chemotherapy.
• PROCRIT^® is not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• PROCRIT^® is not indicated 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 WARNINGS
Click to view the Medication Guide for Patients
Click to view the Patient Instructions for use

IMPORTANT SAFETY INFORMATION

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Contraindications
PROCRIT^® is contraindicated in patients with:

• Uncontrolled hypertension
• Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT^® or other erythropoietin protein drugs
• Serious allergic reactions to PROCRIT^®

PROCRIT^® from multidose vials contains benzyl alcohol and is contraindicated in:

• Neonates, infants, pregnant women, and nursing mothers. When therapy with PROCRIT^® is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.

Additional Important Safety Information

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

• In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 -14 g/dL) to lower targets (9 - 11.3 g/dL), PROCRIT^® and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
• Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
• In controlled clinical trials of patients with cancer, PROCRIT^® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
• In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

• ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

Hypertension

• PROCRIT^® is contraindicated in patients with uncontrolled hypertension. Following initiation and titration of PROCRIT^®, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT^®.
• Appropriately control hypertension prior to initiation of and during treatment with PROCRIT^®. Reduce or withhold PROCRIT^® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

Seizures

• PROCRIT^® increases the risk of seizures in patients with CKD. During the first several months following initiation of PROCRIT^®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency.

Lack or Loss of Hemoglobin Response to PROCRIT^®

• For lack or loss of hemoglobin response to PROCRIT^®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to PROCRIT^® therapy.

Pure Red Cell Aplasia

• Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with PROCRIT^®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which PROCRIT^® is not approved).
• If severe anemia and low reticulocyte count develop during treatment with PROCRIT^®, withhold PROCRIT^® and evaluate patients for neutralizing antibodies to erythropoietin. Contact Janssen Biotech, Inc. (1-800-457-6399), to perform assays for binding and neutralizing antibodies. Permanently discontinue PROCRIT^® in patients who develop PRCA following treatment with PROCRIT^® or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious Allergic Reactions

• Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with PROCRIT^®. Immediately and permanently discontinue PROCRIT^® and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs.

Laboratory Monitoring

• Evaluate transferrin saturation and serum ferritin prior to and during PROCRIT^® treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.

PROCRIT^® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Chemotherapy-Induced Anemia

• PROCRIT^® is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
• PROCRIT^® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• Initiate PROCRIT^® in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
• Use the lowest dose of PROCRIT^® necessary to avoid RBC transfusions.
• Reduce dose by 25% if:
  • Hemoglobin increases greater than 1 g/dL in any 2-week period or
  • Hemoglobin reaches a level needed to avoid RBC transfusion.
• Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
• Adverse reactions in ≥5% of PROCRIT^®-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.

Talk to your doctor if you have any questions about this information.
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.

Please see Full Prescribing Information

Medication Guide for PROCRIT^®
Please read the Medication Guide for PROCRIT^® and discuss with your doctor.

Patient Instructions for Use

Instructions if you or your caregiver has been trained to give PROCRIT^® injections at home.

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ZYTIGA^® (abiraterone acetate)

What is ZYTIGA^®?
ZYTIGA^® (Zye-tee-ga) 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 and who have previously received treatment with docetaxel.

IMPORTANT SAFETY INFORMATION

Who should not take ZYTIGA^®?
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.

• have heart problems
• have liver problems
• have a history of adrenal and/or pituitary problems
• have any other medical conditions
• plan to become pregnant
• 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.
• 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. 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.
• ZYTIGA^® is supplied as 250-mg tablets and the usual dose of ZYTIGA^® is four tablets taken once daily.
• 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^®.
• 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 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:
• joint swelling or pain
• muscle aches
• hot flushes
• diarrhea
• urinary tract infection
• cough
• irregular heartbeats
• urinating more often than normal
• need to get up at night to urinate
• heartburn
• cold-like symptoms
• bone fractures
• 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 many 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 at 1-800-FDA-1088 (1-800-332-1088).

Please see Full Product Information in PDF format, for more details.

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