Pegfilgrastim Side Effects

Some side effects of pegfilgrastim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pegfilgrastim: subcutaneous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking pegfilgrastim: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pegfilgrastim and call your doctor at once if you have a serious side effect such as:

• sudden or severe pain in your left upper stomach spreading up to your shoulder;

• severe dizziness, skin rash, or flushing (warmth, redness, or tingly feeling);

• rapid breathing or feeling short of breath;

• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness; or

• bruising, swelling, pain, redness, or a hard lump where the injection was given.

Less serious side effects of pegfilgrastim may include:

• bone pain;

• pain in your arms or legs; or

• bruising, swelling, pain, redness, or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pegfilgrastim: subcutaneous solution

Musculoskeletal

Musculoskeletal side effects associated with the administration of pegfilgrastim have included medullary bone pain, occurring in 26% of clinical trials patients.

Metabolic

Metabolic side effects associated with the administration of pegfilgrastim have included reversible elevations in LDH (19%), alkaline phosphatase (9%), and uric acid (8%). Treatment intervention was not necessary.

Hematologic

Hematologic side effects including splenic rupture have been reported rarely following the administration of filgrastim (the parent compound of pegfilgrastim) when used for peripheral blood progenitor cell mobilization in both healthy donors and patients with cancer. The administration of pegfilgrastim has been associated with asymptomatic leukocytosis (less than 1 %).

Pegfilgrastim should not be used for peripheral blood progenitor cell mobilization. Patients receiving pegfilgrastim who report left upper abdominal or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.

General

General side effects associated with the administration of pegfilgrastim have included many effects that have been associated with the chemotherapy that was given concomitantly. These have included nausea, fatigue, alopecia, diarrhea, vomiting, constipation, fever, anorexia, skeletal pain, headache, taste perversion, dyspepsia, myalgia, insomnia, abdominal pain, arthralgia, generalized weakness, peripheral edema, dizziness, granulocytopenia, stomatitis, mucositis, and neutropenic fever. Most of these effects have been attributed by the investigators to be the result of the underlying condition or the chemotherapy administered.

Respiratory

Respiratory side effects including adult respiratory distress syndrome (ARDS) has been reported with the use of filgrastim (the parent compound of pegfilgrastim).

Because adult respiratory distress syndrome (ARDS) has been reported with the use of filgrastim, patients receiving pegfilgrastim who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS.

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