Infugem Side Effects

Generic name: gemcitabine

Medically reviewed by Drugs.com. Last updated on Jun 20, 2024.

Note: This document provides detailed information about Infugem.

Applies to gemcitabine: intravenous powder for solution, intravenous solution Side Effects associated with gemcitabine. Some dosage forms listed on this page may not apply specifically to the brand name Infugem.

Applies to gemcitabine: intravenous powder for solution, intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Gemcitabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Also, check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause lung problems (eg, interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, adult respiratory distress syndrome), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have new or worsening cough, fever, chest tightness, or trouble breathing.

This medicine may cause kidney problems, including hemolytic uremic syndrome, thrombotic microangiopathy, and kidney failure. Check with your doctor right away if you have stomach pain, blood in the urine, fever, increased or decreased urination, pinpoint red spots on the skin, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

If you plan to have children, talk with your doctor before receiving this medicine. Some men using this medicine have become infertile (unable to have children).

Serious side effects of Infugem

Along with its needed effects, gemcitabine (the active ingredient contained in Infugem) 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 gemcitabine:

Other side effects of Infugem

Some side effects of gemcitabine 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:

For healthcare professionals

Applies to gemcitabine: intravenous powder for injection, intravenous solution.

Hematologic adverse events

• Very common (10% or more): Anemia (68%), neutropenia (63%), leucopenia (62%), thrombocytopenia (24%), petechiae (16%), hemorrhage (17%), bone marrow suppression (usually mild to moderate)
• Common (1% to 10%): Febrile neutropenia
• Very rare (less than 0.01%): Thrombocytosis
• Postmarketing reports: Capillary leak syndrome (CLS)^[Ref]

Myelosuppression is the major dose-limiting factor associated with gemcitabine therapy.

Dosage adjustments for hematologic toxicity are frequently necessary. Less than 1% of patients have had to discontinue therapy for either anemia, leukopenia, or thrombocytopenia. Grade 3/4 thrombocytopenia was more common in the elderly, especially older women.

The risk for thrombotic thrombocytopenic purpura increases as the cumulative dose of gemcitabine approaches 20,000 mg/m2.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea/vomiting (69%), diarrhea (19%), stomatitis (11%), stomatitis and ulceration of the mouth (11%)
• Common (1% to 10%): Constipation
• Very rare (less than 0.01%): Ischemic colitis, anal pruritus^[Ref]

If the patient is not vomiting due to their disease state, nausea can generally be prevented by administration of prochlorperazine or low-dose oral serotonin antagonists and glucocorticoid therapy. One study of 790 patients found the rate of WHO grade 3 nausea and vomiting at a frequency of 22% in patients under 65 years of age, and 12% in patients 65 years of age or older.^[Ref]

Hepatic

• Very common (10% or more): Increased ALT (68%), increased AST (67%), increased alkaline phosphatase (55%), hyperbilirubinemia (13%)

Common (1% to 10%):

• Uncommon (0.1% to 1%): Serious hepatotoxicity (including liver failure and death), increased gamma-glutamyl transferase (GGT)
• Postmarketing reports: Hepatic veno-occlusive disease

No evidence of increased hepatic toxicity has been reported with longer duration or greater total cumulative dose.

Renal

• Very common (10% or more): Proteinuria (45%), hematuria (35%), increased BUN (16%)
• Common (1% to 10%): Increased creatinine (8%)
• Uncommon (0.1% to 1%): Renal failure, hemolytic-uremic syndrome^[Ref]

Renal failure may not be reversible, even upon discontinuation of therapy.^[Ref]

Other

• Very common (10% or more): Fever (41%), asthenia, chills
• Common (1% to 10%): Paresthesia
• Rare (less than 0.1%): Radiation toxicity, radiation recall
• Frequency not reported: Cough, chills, pattern of tissue injury typically associated with radiation toxicity^[Ref]

The flu-like symptoms usually take place a few hours after drug administration. The symptoms are usually self-limiting and recovery is generally within 24 to 48 hours. Less than 1% of patients discontinued use due to flu-like symptoms. Some patients get relief from nonsteroidal anti-inflammatory drugs or acetaminophen.

Out of the five reported cases of distal ischemic changes, four of those case related to combination chemotherapy with cisplatin and gemcitabine (the active ingredient contained in Infugem) while one case was of gemcitabine as a single agent in first-line therapy.^[Ref]

Dermatologic

• Very common (10% or more): Allergic skin rash frequently associated with pruritus (30%), alopecia (15%)
• Common (1% to 10%): Itching, sweating
• Rare (0.01% to 0.1%): Severe skin reactions (including desquamation and bullous skin eruptions), ulceration, vesicle and sore formation, scaling
• Very rare (less than 0.01%): Lyell's syndrome (toxic epidermal necrolysis, Stevens Johnson Syndrome
• Postmarketing reports: Cellulitis^[Ref]

Rash was generally a macular or finely granular maculopapular pruritic eruption, mild to moderate in severity, involving the trunk and extremities. Alopecia is usually minimal.^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (23%)
• Common (1% to 10%): Cough, rhinitis
• Uncommon (0.1% to 1%): Interstitial pneumonitis, bronchospasm
• Rare (0.01% to 0.1%): Pulmonary edema, adult respiratory distress syndrome (ARDS)
• Very rare (less than 0.01%): Respiratory failure/death
• Frequency not reported: Pulmonary fibrosis, pulmonary edema^[Ref]

Some of the dyspnea reported may have been due to underlying disease. Forty percent of the study population consisted of lung cancer patients, while some of the other study patients had pulmonary manifestations of other malignancies.

Different patterns of lung injury may be related to gemcitabine (the active ingredient contained in Infugem) A rapid response following the administration of corticosteroids would mean the respiratory problem was probably due to a hypersensitivity reaction.^[Ref]

Nervous system

• Common (1% to 10%): Headache, insomnia, somnolence, paraesthesia
• Uncommon (0.1% to 1%): Cerebrovascular accident
• Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)^[Ref]

Less than 1% of the paresthesias have been severe.^[Ref]

Local

• Very common (10% or more): Injection site reactions (mainly mild)^[Ref]

Hypersensitivity

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

Cardiovascular

• Uncommon (0.1% to 1%): Arrhythmias (predominantly supraventricular), heart failure
• Rare (less than 0.1%): Hypotension, hypertension, myocardial infarction, atrial fibrillation
• Very rare (less than 0.01%): Congestive heart failure
• Postmarketing reports: Supraventricular arrhythmias^[Ref]

Many of the patients that suffered cardiovascular effects had a prior history of cardiovascular disease. Two percent of patients discontinued therapy due to these effects. Less than 1% of patients discontinued due to edema.^[Ref]

Immunologic

• Very common (10% or more): Infection (16%), influenza-like symptoms
• Rare (less than 0.1%): Anaphylactoid reaction
• Frequency not reported: Scleroderma-like reaction^[Ref]

Metabolic

• Very common (10% or more): Edema/peripheral edema-including facial edema (usually reversible after stopping treatment)
• Common (1% to 10%): Anorexia^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, myalgia^[Ref]

See also:

Further information

Infugem 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.

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