Melphalan

• Cancer
• Multiple Myeloma

Take melphalan exactly as prescribed.

Oral:

• This medication comes in tablet form and is usually take once a day, with or without food.
• Response may be very gradual over many months; it is important that repeated courses or continuous therapy be taken since improvement may continue slowly over many months, and the maximum benefit may be missed if treatment is abandoned too soon.
   

Injectable:

• This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store tablets at controlled room temperature 15° to 30°C (59° to 86°F). Protect from light.
• Store injectable in a refrigerator, 2° to 8°C (36° to 46°F). Protect from light.
• Keep this and all medications out of the reach.

Antineoplastic agent; nitrogen mustard derivative; alkylating agent.a b c

Specific Drugs

1. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. U.S. Department of Health and Human Services, Public Health Service. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
   http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.

SAGENT®

Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India
©2016 Sagent Pharmaceuticals, Inc.

May 2016

SAGENT Pharmaceuticals®

• Alkeran
• Evomela

• Antineoplastic Agent, Alkylating Agent
• Antineoplastic Agent, Alkylating Agent (Nitrogen Mustard)

Refer to adult dosing. Use caution and begin at the lower end of dosing range.

Melphalan is hepatically metabolized; however, dosage adjustment does not appear to be necessary (King, 2001).

American Society of Clinical Oncology (ASCO) Guidelines for appropriate chemotherapy dosing in obese adults with cancer (Note: Excludes HSCT dosing): Utilize patient’s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

American Society for Blood and Marrow Transplantation (ASBMT) practice guideline committee position statement on chemotherapy dosing in obesity: Utilize actual body weight (full weight) for calculation of body surface area in melphalan dosing for hematopoietic stem cell transplant conditioning regimens in adults (Bubalo 2014). Note: The manufacturer of Evomela recommends that if patients weigh more than 130% of their ideal body weight, body surface area should be calculated using adjusted ideal body weight.

CBC with differential and platelet count, serum electrolytes, renal/liver function tests, serum uric acid; signs/symptoms of hypersensitivity reaction, pulmonary toxicity, and gastrointestinal toxicity; monitor infusion site.

Melphalan can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with this drug

Do not take these drugs with melphalan. Doing so can cause dangerous effects in the body. Examples of these drugs include:

• Live vaccines, such as the nasal flu vaccine and measles, mumps, and rubella vaccine. You shouldn’t receive live vaccines during treatment with this drug. This medication weakens your immune system, so it may not be strong enough to receive live vaccines. Tell your doctor if you plan to receive any vaccines.

People with kidney problems

If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of melphalan in your body and cause more side effects. Your doctor may decrease your dose.

People with liver problems

Let your doctor know if you have liver problems or a history of liver disease. This drug can harm your liver and make your liver problems worse.

Pregnant women

Melphalan is a category D pregnancy drug. That means two things:

1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or planning to become pregnant.

Since melphalan can cause serious harm to a pregnancy, you should use effective birth control during treatment. Ask your doctor about birth control options that may be right for you.

Women who are breast-feeding

It isn’t known if melphalan passes into breast milk. If it does, it may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication. You shouldn’t do both.

For seniors

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years of age.

When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

Allergies

Melphalan can cause a severe allergic reaction. Symptoms can include:

• itching
• hives
• rash
• swelling of your face, mouth, or throat
• wheezing
• trouble breathing
• fast heartbeat
• low blood pressure (may make you feel dizzy or lightheaded)

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Taking this drug again if you’ve ever had an allergic reaction to it could be fatal (cause death). Be sure to tell your doctor if you’ve ever had an allergic reaction to this drug.