Peginesatide Side Effects

Some side effects of peginesatide 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 peginesatide: injectable solution

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

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Peginesatide can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use peginesatide. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• numbness, tingling, cold feeling, or pale appearance in your arms or legs;

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• feeling light-headed, fainting; or

• if your hemodialysis vein access stops working.

Call your doctor at once if you have any other serious side effect such as:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• feeling light-headed, fainting;

• pale skin, feeling short of breath, rapid heart rate, trouble concentrating;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

• fever;

• seizure (convulsions); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of peginesatide may include:

• nausea, vomiting, diarrhea;

• cough;

• headache;

• back pain, muscle spasm, pain in your arms or legs;

• joint pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 peginesatide: injectable solution

Cardiovascular

Cardiovascular side effects have included hypotension (14.2%), hypertension (13.2%), and procedural hypotension (10.9%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (18.4%), nausea (17.4%), and vomiting (15.3%).

General

General side effects have included pyrexia (12.2%).

Immunologic

Immunologic side effects have included the development of peginesatide specific antibodies (1.2%).

Metabolic

Metabolic side effects have included hyperkalemia (11.4%).

Musculoskeletal

Musculoskeletal side effects have included muscle spasms (15.3%), pain in extremity (10.9%), back pain (10.9%), and arthralgia (10.7%).

Nervous system

Nervous system side effects have included headache (15.4%).

Other

Other side effects have included arteriovenous fistula site complication (16.1%).

Respiratory

Respiratory side effects have included dyspnea (18.4%), cough (15.9%), and upper respiratory infection (11.0%).

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of serious allergic reactions including fatal reactions (0.02%).

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