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Granix Side Effects

Generic Name: tbo-filgrastim

Note: This document contains side effect information about tbo-filgrastim. Some of the dosage forms listed on this page may not apply to the brand name Granix.

For the Consumer

Applies to tbo-filgrastim: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, tbo-filgrastim (the active ingredient contained in Granix) 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 tbo-filgrastim:

More common

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • bone pain
  • fever
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Rare

Incidence not known

  • Blisters or fever sores on the skin
  • bloody or cloudy urine
  • chest pain or tightness
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • pain in the upper left part of the stomach or at the tip of the left shoulder
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • trouble breathing
  • unusual weakness
  • weight gain

Side effects not requiring immediate medical attention

Some side effects of tbo-filgrastim 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:

More common

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • lack or loss of strength

For Healthcare Professionals

Applies to tbo-filgrastim: subcutaneous solution

Cardiovascular

Very common (10% or more): Thrombocytopenia (up to 34%)

Frequency not reported: Aortitis, capillary leak syndrome

In a clinical trial, thrombocytopenia occurred in 34% of pediatric patients (n=50) given 5 mcg/kg subcutaneously once a day starting one day after chemotherapy.

Gastrointestinal

In a clinical trial, diarrhea occurred in 6% of pediatric patients (n=50) given 5 mcg/kg subcutaneously once a day starting one day after chemotherapy.[Ref]

Common (1% to 10%): Diarrhea

Frequency not reported: Vomiting[Ref]

Musculoskeletal

Common (1% to 10%): Bone pain, extremity pain

Frequency not reported: Myalgia[Ref]

In a clinical trial, extremity pain occurred in 6% of pediatric patients (n=50) given 5 mcg/kg subcutaneously once a day starting one day after chemotherapy.[Ref]

Other

In a clinical trial, pyrexia occurred in 8% of pediatric patients (n=50) given 5 mcg/kg subcutaneously once a day starting one day after chemotherapy.[Ref]

Common (1% to 10%): Pyrexia

Postmarketing reports: Asthenia, fatigue[Ref]

Nervous system

Common (1% to 10%): Headache

In a clinical trial, headache occurred in 6% of pediatric patients (n=50) given 5 mcg/kg subcutaneously once a day starting one day after chemotherapy.

Immunologic

Common (1% to 10%): Anti-drug antibodies to this drug

Hematologic

Frequency not reported: Fatal splenic rupture, leukocytosis, sickle cell disorders[Ref]

Dermatologic

Frequency not reported: Cutaneous vasculitis

Postmarketing reports: Acute febrile neutrophilic dermatosis, Sweet's syndrome[Ref]

Oncologic

Frequency not reported: Potential for tumor growth stimulatory effects on malignant cells

Hypersensitivity

Frequency not reported: Serious allergic reactions

Respiratory

Frequency not reported: Acute respiratory distress syndrome

Renal

Frequency not reported: Glomerulonephritis

References

1. "Product Information. Granix (tbo-filgrastim)." Teva Pharmaceuticals USA, North Wales, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.