Hepzato Side Effects

Generic name: melphalan

Medically reviewed by Drugs.com. Last updated on Nov 28, 2023.

Note: This document contains side effect information about melphalan. Some dosage forms listed on this page may not apply to the brand name Hepzato.

Applies to melphalan: powder for solution. Other dosage forms:

oral tablet

Warning

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, MyelosuppressionSevere 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

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

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

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, oral tablet.

Hematologic

thrombocytopenia, anemia)

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

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]