IVRA™
(Melphalan) Injection 90 mg/mL
This site is intended for U.S. healthcare professionals. | Full Prescribing Information
ABOUT ORDERING BILLING & CODING
This site is intended for U.S. healthcare professionals. | Full Prescribing Information
IVRA™
(Melphalan) Injection 90 mg/mL
ABOUT ORDERING BILLING & CODING

IVRATM

(Melphalan) Injection 90 mg/mL

The Clearer Choice
IVRATM (Melphalan) Injection is a multi-dose vial—
making storage, administration, and disposal more efficient.
IVRATM (Melphalan) Injection is a multi-dose vial— making storage, administration, and disposal more efficient.
Less drug wastage | Fewer bottles to store | Fewer hazardous waste items requiring proper disposal protocols
IVRATM
(multi-dose)
Other Melphalan Hydrochloride Injections
* For visual representation purposes only of multiple single doses.




About IVRATM (Melphalan) Injection 90 mg/mL
IVRATM is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
EFFICIENT
For visual representation purposes only.
STABLE
IVRATM
28 days after first use (refrigerated)*
OTHER MELPHALAN
HYDROCHLORIDE INJECTIONS
1 Hour Once Reconstituted
* IVRATM (melphalan) Injection 90 mg/mL is light sensitive. After first use, store the partially used vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton for use within 28 days and then discard the remaining contents. Retain vial in original carton until contents are used.
Apotex Customer Service
Email for more information or with questions about IVRATM
ivra@apotexcorp.com



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Important Safety Information for IVRATM (Melphalan) Injection 90 mg/mL

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

  • Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters.
  • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions.
  • Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans.
 
 
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Important Safety Information for IVRATM (Melphalan) Injection 90 mg/mL

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

  • Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters.
  • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions.
  • Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans.

Contraindications

  • Melphalan Injection is contraindicated in patients with a history of severe hypersensitivity to melphalan. Reactions have included anaphylaxis.

Warnings and Precautions

  • Bone Marrow Suppression: IVRA causes bone marrow suppression in most patients. Obtain complete blood counts with differential at the start of therapy and prior to each subsequent dose of IVRA. Withhold treatment for grade 3 thrombocytopenia and/or leukopenia until blood counts have returned to grade 2. Consider dose adjustment on the basis of blood counts at the nadir and day of treatment.
  • Secondary Malignancies: Melphalan has been shown to cause chromatid or chromosome damage in humans. Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patients with cancer treated with alkylating agents (including melphalan). Some patients also received other chemotherapeutic agents or radiation therapy. The potential benefits from melphalan therapy must be weighed on an individual basis against the possible risk of the induction of a second malignancy.
  • Impairment of Fertility: Melphalan causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients. Reversible and irreversible testicular suppression have also been reported.
  • Embryo-Fetal Toxicity: IVRA can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise a pregnant woman of the of potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with IVRA and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with IVRA and for 3 months after the last dose.
  • Hypersensitivity: Acute hypersensitivity reactions including anaphylaxis were reported in 2.4% of 425 patients receiving melphalan injection for myeloma. These reactions were characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. These patients appeared to respond to antihistamine and corticosteroid therapy. If a hypersensitivity reaction occurs, IV or oral melphalan should not be readministered since hypersensitivity reactions have also been reported with oral melphalan. Cardiac arrest has also been reported rarely in association with such reports.

Adverse Events

The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with melphalan were neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.

Use in Specific Populations

  • Lactation: IVRA should not be given to nursing mothers.
  • Renal Impairment: Consider a dosage reduction in patients with renal insufficiency receiving intravenous IVRA. In one trial, increased bone marrow suppression was observed in patients with elevated BUN.

Please click here for Full Prescribing Information, including BOXED WARNINGS, for IVRATM (Melphalan) Injection 90 mg/mL.