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TARO-MELPHALAN is a brand name for Melphalan, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-MELPHALAN (melphalan) is indicated for: • the palliative treatment of multiple myeloma • the palliation of nonresectable epithelial carcinoma of the ovary. • TARO-MELPHALAN for injection has been administered by hyperthermic isolated limb perfusion as an adjuvant to surgery in the treatment of malignant melanoma.…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution 01/2026 7 WARNINGS AND PRECAUTIONS 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................................
2 TABLE OF CONTENTS ............................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................................
4 1 INDICATIONS ................................................................................................................................... 1 Pediatrics .................................................................................................................................................
2 Geriatrics ................................................................................................................................................. 4 2 CONTRAINDICATIONS ..............................................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................................................
1 Dosing Considerations ............................................................................................................................ 2 Recommended Dose and Dosage Adjustment ......................................................................................
3 Reconstitution ......................................................................................................................................... 4 Administration.........................................................................................................................................
5 Missed Dose ............................................................................................................................................ 7 5 OVERDOSAGE ...........................................................................................................................................
). Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of volume expanders, pressor agents, corticosteroids, or antihistamines at the discretion of the physician. Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Therefore, immunisations with live organism vaccines are not recommended. Monitoring and Laboratory Tests Periodic complete blood counts with differentials should be performed during the course of treatment with melphalan. At least one determination should be obtained prior to each dose.
Patients should be observed closely for consequences of bone marrow suppression, which include severe infections, bleeding, and symptomatic anemia. Taro-Melphalan 5 0 mg /vial Page 10 of 23 ` Renal Systemic exposure of melphalan was positively correlated to the degree of renal insufficiency following either route of administration.
In one trial by Cornwell et al. (1982), increased incidence rate of bone marrow suppression has been associated with impaired renal function in patients with intravenous administration without dose adjustment for renal failure. Dose adjustments should be considered for patients with significant renal dysfunction (BUN ≥ 30mg/dL) and these patients should be closely monitored for toxicity.
The use of high dose melphalan has the potential to cause acute kidney injury in patients, especially those with underlying renal impairment.
Reproductive Health:
Female and Male Potential Due to an increased risk of venous thromboembolism in patients undergoing treatment with melphalan in combination with lenalidomide and prednisone or in combination with thalidomide and prednisone or dexamethasone, combined oral contraceptive pills are not recommended.
01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................................
2 TABLE OF CONTENTS ............................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................................
4 1 INDICATIONS ................................................................................................................................... 1 Pediatrics .................................................................................................................................................
2 Geriatrics ................................................................................................................................................. 4 2 CONTRAINDICATIONS ..............................................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................................................
1 Dosing Considerations ............................................................................................................................ 2 Recommended Dose and Dosage Adjustment ......................................................................................
3 Reconstitution ......................................................................................................................................... 4 Administration.........................................................................................................................................
TARO-MELPHALAN is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition and Packaging.
• Patients whose disease has demonstrated a prior resistance to this agent. There may be cross-sensitivity (skin rash) between melphalan and chlorambucil. • Patients who have recently been administered other similar chemotherapeutic agents or radiotherapy, or if neutrophil and/or platelet counts are depressed (see 7 WARNINGS and PRECAUTIONS, Hematologic).
• Patients who are receiving radiotherapy. 2 Breast-feeding). Taro-Melphalan 5 0 mg /vial Page 5 of 23 `
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Melphalan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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If a patient is currently using combined oral contraception, her partner should switch to a barrier method like condom. The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception. Considering that Melphalan has been shown to cause chromatid or chromosome damage in man, it is recommended that men who are receiving treatment with Melphalan not father a child during treatment and up to 6 months afterwards.
As with all cytotoxic treatments, male and female patients who use melphalan should use effective and reliable contraceptive methods for a period of six months, following the cessation of treatment. The final decision regarding the additional time period on contraception should be taken by the doctor and/or the patient.
• 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. There is evidence from some animal studies that melphalan can have an adverse effect on spermatogenesis.
It is recommended that men have a consultation on sperm preservation before treatment due to the possibility of irreversible infertility as a result of Melphalan treatment. Respiratory Rare reports of pulmonary fibrosis or interstitial pneumonitis (including fatal reports) have been seen in patients treated with TARO-MELPHALAN.
1 Pregnant Women Safe use of melphalan has not been established with respect to adverse effects on fetal development. Therefore, it should be used in women of childbearing potential and particularly during early pregnancy only when, in the judgment of the physician, the potential benefits outweigh the possible hazards.
2 Breast-feeding It is not known whether this drug is excreted in human milk. Because many drugs are excreted in Taro-Melphalan 5 0 mg /vial Page 11 of 23 ` human milk and because of the potential for serious adverse reactions in nursing infants from melphalan, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see 2 CONTRAINDICATIONS).
3 Pediatrics Pediatrics (< 18 years): The safety and effectiveness in children have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Clinical experience with TARO-MELPHALAN has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see 7 Renal).
1 Adverse Reaction Overview The following information on adverse reactions is based on data from both oral and intravenous administration of melphalan as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.
For this product, there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the indication and dose received and also when given in combination with other therapeutic agents.
Gastrointestinal:
Gastrointestinal effects such as nausea and vomiting occur in up to 50% of patients receiving intravenous doses of melphalan. Diarrhea is noted to occur one week post high dose melphalan therapy. Oral ulceration and hepatic toxicity including veno-occlusive disease have been reported.
The incidence of diarrhea, vomiting and stomatitis becomes the dose-limiting toxicity in patients given high intravenous doses of melphalan in association with autologous bone marrow transplantation. Cyclophosphamide pretreatment appears to reduce the severity of gastrointestinal damage induced by high-dose melphalan and the literature should be consulted for details.
Stomatitis at conventional doses is rare.
Hematologic:
The most common side effect is bone marrow suppression leading to […]
5 Missed Dose ............................................................................................................................................ 7 5 OVERDOSAGE ...........................................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................................... 7 7 WARNINGS AND PRECAUTIONS ..............................................................................................................
1 Special Populations ............................................................................................................................... 1 Pregnant Women ..................................................................................................................................
2 Breast-feeding ....................................................................................................................................... 3 Pediatrics ...............................................................................................................................................
4 Geriatrics ............................................................................................................................................... 11 8 ADVERSE REACTIONS .............................................................................................................................
1 Adverse Reaction Overview .................................................................................................................. 11 9 DRUG INTERACTIONS.............................................................................................................................
3 Drug-Behavioural Interactions.............................................................................................................. 4 Drug-Drug Interactions .........................................................................................................................
5 Drug-Food Interactions ......................................................................................................................... 6 Drug-Herb Interactions .........................................................................................................................
7 Drug-Laboratory Test Interactions ....................................................................................................... 13 10 CLINICAL PHARMACOLOGY ..............................................................................................................
1 Mechanism of Action............................................................................................................................... 3 Pharmacokinetics ....................................................................................................................................
14 11 STORAGE, STABILITY AND DISPOSAL ............................................................................................... 15 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................................
15 PART II: SCIENTIFIC INFORMATION ............................................................................................................... 16 13 PHARMACEUTICAL INFORMATION ..................................................................................................
16 14 CLINICAL TRIALS ................................................................................................................................ 16 15 MICROBIOLOGY ................................................................................................................................
16 16 NON-CLINICAL TOXICOLOGY […]