FDA-filed SPL labeling · retrieved through openFDA

Melphalan

Melphalan is a chemotherapy drug used to treat multiple myeloma, available in injectable forms (Evomela, Ivra) and an oral tablet (Alkeran).

Brand names Alkeran TabletsAlkeranEvomelaHepzatoIvra
Drug class ⓘ Alkylating Drug
Rx Forms 2 Routes Intravenous · Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 9 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 9, 2023
Clinical labels in scope ⓘ9
AvailabilityRx
Earliest approval/marketing year ⓘ1964
FDA-listed product records ⓘ55
Boxed warningYes
How we combine label and product data →
Other forms & routes:
Injection
⭐ Melphalan at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Melphalan is a powerful chemotherapy drug used to treat multiple myeloma — either to prepare the body for a stem cell transplant (Evomela) or as ongoing palliative treatment (Ivra, Alkeran). It carries serious risks, especially to blood cell production and long-term cancer risk, so it is only used under close medical supervision with regular blood monitoring. Following your care team's instructions carefully and reporting any signs of infection, bleeding, or allergic reaction right away is essential.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Melphalan carries serious black-box warnings that every patient should know about.

Severe bone marrow suppression: Melphalan can dramatically reduce your body's ability to make blood cells, leading to life-threatening infections or bleeding. IV melphalan causes more of this effect than oral melphalan. Your blood counts will be monitored closely throughout treatment.

Severe allergic reactions: About 2% of patients receiving IV melphalan have experienced serious hypersensitivity reactions — including anaphylaxis (a sudden, life-threatening allergic response). Signs include hives, swelling, trouble breathing, rapid heartbeat, and low blood pressure. If a serious reaction occurs, Ivra must be stopped immediately and should not be restarted.

Risk of causing a new cancer (leukemogenicity): Melphalan can damage chromosomes and has been linked to the development of secondary cancers, including certain leukemias. Ivra in particular should be considered potentially capable of causing leukemia in humans.

Read the full warning on DailyMed →

📖 Melphalan: Patient Information Guide

A plain-language walkthrough of Melphalan — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Melphalan is a chemotherapy drug approved for use in multiple myeloma. Different products are approved for different roles:

  • Evomela (intravenous injection) is indicated as a high-dose conditioning regimen prior to autologous hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
  • Ivra (intravenous injection) is indicated for the palliative treatment of multiple myeloma in patients for whom oral therapy is not appropriate.
  • Alkeran (oral tablet) is used for the palliative treatment of multiple myeloma.
⚙️How it works▾

Melphalan belongs to a class of chemotherapy drugs called alkylating agents. It works by chemically bonding to DNA inside cancer cells — specifically cross-linking the two strands of the DNA double helix together at a site called the N7 position of guanine. This damage prevents the cell from reading or copying its DNA, which stops it from dividing and ultimately causes the cancer cell to die. Unlike some chemotherapy drugs that only target rapidly dividing cells, melphalan is also active against cancer cells that are in a resting state.

💊How it's taken▾

Melphalan is available as an intravenous (IV) injection and as an oral tablet, and dosing depends entirely on which product and indication applies to you — always follow your prescriber's exact plan.

  • Evomela (IV) is given as a daily infusion over about 30 minutes for two consecutive days prior to a stem cell transplant.
  • Ivra (IV) is infused over 15 to 20 minutes — typically every two weeks for the first four doses, then every four weeks based on how your blood counts recover.
  • Alkeran (oral tablet) is taken by mouth on a schedule determined by your prescriber; repeated treatment courses are often needed since improvement can be gradual over many months.

Your blood counts will guide dose adjustments throughout treatment. Never stop or change your dose without talking to your care team first.

🤒Side effects — in detail▾

Melphalan affects blood cell production in nearly all patients, and many other side effects are possible depending on the dose and formulation used.

  • Decreased neutrophils, white blood cells, lymphocytes, and platelets (expected in almost all patients)
  • Anemia (low red blood cells)
  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Mouth sores (stomatitis, mucosal inflammation)
  • Low potassium (hypokalemia) and low phosphate (hypophosphatemia)
  • Fever, including febrile neutropenia (fever with dangerously low white blood cell counts)
  • Decreased appetite, dizziness, constipation, abdominal pain

Seek immediate medical attention for signs of serious infection (fever, chills), unusual bleeding or bruising, symptoms of a severe allergic reaction (difficulty breathing, swelling, rapid heartbeat), or yellowing of the skin or eyes.

⚠️Warnings & precautions▾
  • Severe bone marrow suppression: Melphalan suppresses bone marrow function in most patients, reducing blood cells and increasing the risk of serious infection and bleeding. Blood counts must be monitored before every dose. IV melphalan causes more suppression than oral melphalan.
  • Serious allergic reactions (hypersensitivity/anaphylaxis): About 2% of patients receiving IV melphalan have had severe reactions, including life-threatening anaphylaxis. If this occurs, IV melphalan must be stopped and should not be restarted — oral melphalan has also caused reactions.
  • Secondary cancers: Melphalan can damage chromosomes and has been associated with the development of secondary leukemias and other cancers. This long-term risk must be weighed against the benefit of treating multiple myeloma.
  • Liver toxicity (hepatotoxicity): Liver problems ranging from abnormal lab values to hepatitis, jaundice, and veno-occlusive disease (blockage of blood vessels in the liver) have been reported. Liver enzymes should be monitored.
  • Fetal harm: Melphalan can cause serious birth defects or pregnancy loss. Effective contraception is required during and after treatment.
  • Fertility effects: Melphalan can suppress ovarian function in women and testicular function in men — these effects may or may not be reversible.
  • Gastrointestinal toxicity: Nausea, vomiting, diarrhea, and mouth sores are common; at high doses, severe colitis and gastrointestinal bleeding can occur.
🔀What it interacts with▾

Melphalan can interact with several other medications in ways that increase the risk of serious harm. Tell your care team about everything you take.

  • Cyclosporine: A single IV dose of melphalan followed by standard oral cyclosporine doses has caused severe kidney failure.
  • Cisplatin: This chemotherapy drug can reduce kidney function, which in turn affects how the body clears melphalan — potentially increasing melphalan's effects and toxicity.
  • BCNU (carmustine): IV melphalan may lower the dose of BCNU needed to cause lung toxicity, increasing that risk.
  • Nalidixic acid: When given at the same time as IV melphalan, this antibiotic has been linked to a higher rate of severe, hemorrhagic (bleeding) bowel inflammation, particularly in children.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Severe prior allergic reaction to melphalan: Ivra is contraindicated if you have had a serious hypersensitivity reaction to melphalan — tell your doctor before starting any melphalan product.
  • Kidney problems: Impaired kidney function can affect how melphalan is cleared; a dose reduction may be needed, especially with IV formulations.
  • Liver problems: Liver function should be monitored during treatment; hepatic disorders have been reported.
  • Pregnancy: Melphalan can cause fetal harm or pregnancy loss. Females of reproductive potential should use effective contraception during treatment and for 6 months after the last dose of IV melphalan.
  • Males with reproductive-age partners: Melphalan may damage sperm and cause genetic harm to a fetus; use effective contraception during treatment and for 3 months after the last dose of IV melphalan.
  • Breastfeeding: Do not breastfeed during treatment or for at least one week after the last IV dose — melphalan's effects on a breastfed infant are unknown but potentially serious.
  • Children: The safety and effectiveness of IV melphalan have not been established in pediatric patients.
  • Older adults: Elderly patients should be started at lower doses with caution, as age-related declines in kidney, liver, and heart function can increase the risk of side effects.
🚑If you take too much▾

Overdose with melphalan is very serious and has caused death. Too much can produce severe nausea and vomiting, decreased consciousness, seizures (convulsions), muscle paralysis, and severe damage to the mouth, bowels, and gastrointestinal tract. The most dangerous effect is profound bone marrow suppression, which requires close monitoring of blood counts for three to six weeks after an overdose. There is no specific antidote; treatment is supportive care, and melphalan is not effectively removed by dialysis.

📡Pharmacodynamics — effects in the body▾

Melphalan exerts its anti-cancer effects by cross-linking the two strands of DNA inside tumor cells, which prevents those cells from replicating. It is active against both resting and rapidly dividing cancer cells. The main measurable effect in patients is bone marrow suppression — nearly all patients experience significant decreases in white blood cells, neutrophils, lymphocytes, and platelets during treatment, which is monitored closely to guide dosing.

🔬Pharmacokinetics — how your body processes it▾

After IV injection, melphalan levels in the blood drop rapidly in two phases: an initial distribution phase with a half-life of about 10 minutes, followed by a longer elimination phase with a half-life of about 75 minutes. The drug binds extensively to plasma proteins (53–92%), primarily albumin. Melphalan does not significantly penetrate the fluid around the brain and spinal cord. It is broken down mainly by a natural chemical process (hydrolysis) in the blood rather than by the liver, producing two inactive breakdown products. Very little is removed by the kidneys directly, but reduced kidney function can affect overall clearance and increase the risk of toxicity, so dose reductions are considered in patients with kidney impairment.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F). Protect from light.

📄 Written from Melphalan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

25

Supplements & herbs that interact with Melphalan

25 supplements and herbal products have documented interactions with Melphalan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 14
  • Minor · 10
ACTIVATED CHARCOAL Major ACEROLA Moderate ALPHA-LIPOIC ACID Moderate COENZYME Q10 Moderate COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate +17 more
Every supplement checked against Melphalan — ranked by severity The full interaction hub: 1 major · 14 moderate · 10 minor · every one linked to its full report. Check Melphalan against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Melphalan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

VITAMIN E Insufficient Evidence
See the full Melphalan nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Melphalan — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is melphalan being used for in my case? ▾
Melphalan is a chemotherapy drug used specifically for multiple myeloma — a cancer of certain immune cells in the bone marrow. Depending on which product you're receiving, it may be working to prepare your body for a stem cell transplant (that's what Evomela does) or to slow and control the disease when oral treatment isn't the right option (that's what Ivra or Alkeran does). Your oncologist chose the specific product and approach based on your situation, so ask them which role it's playing for you.
Why do I need so many blood tests during treatment? ▾
Melphalan works partly by suppressing your bone marrow — the place where your body makes blood cells. That means your white blood cells (which fight infection), platelets (which stop bleeding), and red blood cells can all drop significantly. Regular blood counts let your care team catch dangerous drops early and adjust your dose or pause treatment if needed. This monitoring isn't just routine paperwork — it's one of the most important safety measures during your treatment.
What side effects should I actually watch out for and call someone about? ▾
The most important ones to act on quickly are signs of infection — fever, chills, or feeling suddenly much worse — because your immune system will be weakened. Also call right away if you notice unusual bruising or bleeding, or if you have trouble breathing, swelling, hives, or a rapid heartbeat, which could signal a serious allergic reaction. Nausea, diarrhea, fatigue, and mouth sores are very common and your team will help you manage them, but if any of these become severe or you see blood in your stool, get medical help promptly.
Can I get pregnant or father a child during treatment? ▾
This is really important to talk about with your doctor before starting. Melphalan can cause serious harm to a developing baby, including birth defects or pregnancy loss. If you're a woman of childbearing age, you'll need to use reliable contraception during treatment and for 6 months after your last IV dose. If you're a man whose partner could become pregnant, you'll need contraception during treatment and for 3 months after. Melphalan can also affect fertility — it can suppress ovarian function in women and testicular function in men, and those effects aren't always reversible, so it's worth discussing fertility preservation options with your team before you start.
Are there medications I need to avoid while on melphalan? ▾
Yes — a few interactions are worth knowing. Cyclosporine combined with IV melphalan has caused serious kidney failure in some patients. The chemotherapy drug cisplatin can affect how your body processes melphalan. And an antibiotic called nalidixic acid given at the same time as IV melphalan has been linked to severe bowel inflammation. Always give your full medication list — including any supplements — to everyone on your care team so they can check for problems before adding anything new.
Is there a risk of getting another cancer from this treatment? ▾
Yes, and it's something your oncologist will have discussed with you when weighing your treatment options. Melphalan belongs to a class of drugs that can damage DNA, and there is a real — though hard to predict exactly — risk of developing a secondary cancer, including certain types of leukemia, years down the road. The risk appears to increase with higher total doses over time. Your team has already considered this against the serious risks of untreated myeloma. If you have questions or concerns about this, it's absolutely worth raising them with your oncologist.
Is Melphalan available over the counter? ▾
Melphalan is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Melphalan first available? ▾
Melphalan has been available in the United States since at least 1964, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Melphalan? ▾
Melphalan is supplied by 38 manufacturers listed in the FDA NDC Directory, including Mylan Institutional LLC, Meitheal Pharmaceuticals Inc., Dr.Reddy's Laboratories Inc.

💬 Answers drafted from Melphalan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Melphalan supplement interactions25 checked — ranked by severity 🌿Drug & Supplement CheckerMelphalan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Melphalan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Melphalan comes

Melphalan is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands Evomela Ivra
How this form is used
What it may be used for
  • Evomela is used as a high-dose conditioning treatment before autologous stem cell transplantation in patients with multiple myeloma
  • Ivra is used for palliative treatment of multiple myeloma in patients for whom oral therapy is not appropriate
Important instructions
  • Evomela is administered by IV infusion over approximately 30 minutes on two consecutive days before the stem cell transplant
  • Ivra is administered by IV infusion over 15 to 20 minutes, every two weeks for four doses, then every four weeks
  • Both Evomela and Ivra are given by healthcare professionals in a clinical setting — never self-administered
  • Ivra should not be injected directly into a peripheral vein; it should be given through a fast-running IV line or a central venous line to avoid tissue damage
Available strengths 2 strengths
50 mg/10 mL 90 mg/mL
6 FDA-listed product records ⓘ

Tablet

By mouth
Brands Alkeran
How this form is used
What it may be used for
  • Alkeran tablets are used for palliative treatment of multiple myeloma
Important instructions
  • Alkeran is taken by mouth as directed by your prescriber; follow your dosing schedule carefully
  • Repeated courses of Alkeran may be needed — improvement can be slow over many months, so do not stop treatment early without talking to your doctor
Available strengths 1 strength
2 mg
1 FDA-listed product record ⓘ

📊 Melphalan across the U.S. market

How Melphalan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
38
Manufacturers
5
Brand names
55
FDA-listed product records ⓘ
1964
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Kit (31) · Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Mylan Institutional LLC5%
Meitheal Pharmaceuticals Inc.5%
Dr.Reddy's Laboratories Inc5%
BPI Labs LLC5%
Acrotech Biopharma LLC4%
Sionc Pharmaceutical Private Limited4%
Other makers71%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Melphalan products

A representative set of FDA-listed product records for Melphalan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 55 of 55 products — FDA National Drug Code Directory. See every product, package size and price: browse all 55 Melphalan NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Melphalan RxCUI 6718 3 dose forms · 3 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 2708997 In current FDA listings
    Clinical drug / strength (SCD) 90 MG/ML RxCUI 2708998
  2. Dose form (SCDF) Injection RxCUI 1740949 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 311487
  3. Dose form (SCDF) Oral Tablet RxCUI 372756 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 197919

Look up RxCUI 6718 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Alkeran Tablets Alkeran Evomela Hepzato Ivra

🏭 Manufacturers & labelers

Mylan Institutional LLC 3 Meitheal Pharmaceuticals Inc. 3 Dr.Reddy's Laboratories Inc 3 BPI Labs LLC 3 Acrotech Biopharma LLC 2 Sionc Pharmaceutical Private Limited 2 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2 Fresenius Kabi USA, LLC 2 Fosun Pharma USA Inc 2 Acrotech Biopharma Inc 2 Apothecon Pharmaceuticals Pvt Ltd 2 Almaject, Inc. 2 Athenex Pharmaceutical Division, LLC. 2 Hubei Honch Pharmaceutical Co., Ltd. 1 Zhejiang ChemPacific Corporation 1 Xiromed, LLC 1 Valary Lab Private Limited 1 Shilpa Pharma Lifesciences Limited 1 Sagent Pharmaceuticals 1 Qilu Pharmaceutical Co., Ltd. 1 Patheon Manufacturing Services LLC 1 Olon SpA 1 Actavis Pharma, Inc. 1 Maeda Inc 1

…and 14 more on the FDA NDC directory.

RxNorm drug class

Melphalan belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Nitrogen mustard analogues
How it works Alkylating Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 9, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Melphalan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Melphalan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
55
Distinct labelers/manufacturers represented
38
Linked representative label ⓘ
Acrotech Biopharma Inc
Linked label effective
Jun 9, 2023
Composite sections available
25
Linked SPL Set ID
69f55869-dc11-408e-8fc7-47634269a52c
Linked SPL Document ID
43f5835c-f395-47a4-aae6-1e81b5f9bb85
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Acrotech Biopharma Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.