Hepzato Side Effects

Generic name: melphalan

Medically reviewed by Drugs.com. Last updated on Jan 18, 2025.

Note: This document provides detailed information about Hepzato Side Effects associated with melphalan. Some dosage forms listed on this page may not apply specifically to the brand name Hepzato.

Applies to melphalan: powder for solution.

Other dosage forms:

• oral tablet

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Alkeran®: Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

Severe bone marrow suppression with resulting infection or bleeding may occur.

Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation.

Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation.

Melphalan is leukemogenic in humans.

Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans

Intravenous route (powder for solution; solution)

Evomela(TM): Severe bone marrow suppression with resulting infection or bleeding may occur.

Controlled trials have shown more myelosuppression with the IV formulation than the oral formulation.

Monitor hematologic laboratory parameters.

Hypersensitivity reactions, including anaphylaxis, have occurred in patients who received the IV formulation of melphalan hydrochloride.

Discontinue treatment with melphalan hydrochloride for serious hypersensitivity reactions.

Melphalan produces chromosomal aberrations in vitro and in vivo.

Melphalan hydrochloride should be considered potentially leukemogenic in humans.

Intra-arterial route (powder for solution)

Warning: Peri-Procedural Complications, Myelosuppression. Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of melphalan.

Assess patients for these adverse reaction during and for at least 72 hours following administration of melphalan.Melphalan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS.Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with melphalan.

Monitor hematologic laboratory parameters and delay additional cycles of melphalan therapy until blood counts have improved.

Serious side effects of Hepzato

Along with its needed effects, melphalan (the active ingredient contained in Hepzato) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking melphalan:

More common side effects

• bleeding gums
• blurred vision
• chest pain
• chills
• confusion
• cough or hoarseness
• coughing up blood
• difficulty in swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• headache
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• nosebleeds
• painful or difficult urination
• paralysis
• pinpoint red spots on skin
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common side effects

• blue lips and fingernails
• coughing that sometimes produces a pink frothy sputum
• dark-colored urine
• fast heartbeat
• increased sweating
• light-colored stools
• no blood pressure or pulse
• pain, redness, or swelling in the arm or leg
• pale skin
• stomach pain
• stopping of the heart
• swelling in the legs and ankles
• unconsciousness
• vomiting
• yellow eyes or skin

Incidence not known

• absent, missed, or irregular menstrual periods
• back or leg pains
• bloated stomach
• chest tightness
• clay-colored stools
• confusion
• fast, pounding, or irregular heartbeat or pulse
• general body swelling
• hives, itching, rash
• indigestion
• light-colored stools
• loss of appetite
• nausea
• noisy breathing
• pain and fullness in the right upper abdomen or stomach
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears
• sore throat
• swelling of the eyes, face, hands, ankles, feet, or lower legs
• unpleasant breath odor
• unusual lumps or masses
• vomiting of blood
• weight gain or loss

Other side effects of Hepzato

Some side effects of melphalan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

• indigestion
• passing of gas
• stomach fullness

Incidence not known

• blue-green to black skin discoloration
• hair loss or thinning of the hair
• pain, redness, soreness, or sloughing of the skin at the injection site
• sores, welting, or blisters

For healthcare professionals

Applies to melphalan: injectable powder for injection, intravenous powder for injection, intravenous solution, oral tablet.

Hematologic adverse events

• Rare (less than 0.1%): Hemolytic anemia^[Ref]

thrombocytopenia, anemia)

Oncologic

• Frequency not reported: Secondary malignancies (e.g., acute nonlymphocytic leukemia, myeloproliferative syndrome, carcinoma^[Ref]

Respiratory

• Rare (less than 0.1%): Interstitial pneumonitis, pulmonary fibrosis
• Frequency not reported: Bronchospasm, dyspnea^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (at high dose)
• Common (1% to 10%): Alopecia (at conventional dose)
• Rare (less than 0.1%): Maculopapular rash, pruritus
• Frequency not reported: Skin hypersensitivity, skin necrosis (rarely requiring skin grafting)^[Ref]

Cardiovascular

• Frequency not reported: Tachycardia, hypotension, vasculitis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea, vomiting, diarrhea, stomatitis (at high dose)
• Rare (less than 0.1%): Stomatitis (at conventional dose)^[Ref]

Hepatic

• Rare (less than 0.1%): Abnormal liver function tests to clinical manifestations such as hepatitis and jaundice; veno-occlusive disease following high dose treatment^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Allergic reactions (e.g., urticaria, edema, skin rashes, anaphylactic shock)^[Ref]

Other

• Very common (10% or more): Warmth, tingling
• Frequency not reported: Chromosome damage^[Ref]

Renal

• Common (1% to 10%): Temporary significant elevation of the blood urea has been seen in the early stages of therapy with this drug in myeloma patients with renal damage^[Ref]

Local

• Frequency not reported: Skin ulceration at injection site^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle atrophy, muscle fibrosis, myalgia, blood creatine phosphokinase increased
• Common (1% to 10%): Compartment syndrome
• Frequency not reported: Muscle necrosis, rhabdomyolysis^[Ref]

Further information

Hepzato side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer