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Conestat alfa Side Effects

For the Consumer

Applies to conestat alfa: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very bad dizziness or passing out.
  • Change in color of mouth to blue.
  • A fast heartbeat.
  • Very bad headache.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Headache.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to conestat alfa: intravenous powder for injection

General

The most common adverse reactions were headache, nausea, and diarrhea.[Ref]

Nervous system

Very common (10% or more): Headache (up to 10%)
Common (1% to 10%): Vertigo, procedural headache
Uncommon (0.1% to 1%): Paresthesia[Ref]

Dermatologic

Common (1% to 10%): Angioedema, erythema marginatum, skin burning sensation
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Rash[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea
Uncommon (0.1% to 1%): Abdominal discomfort, oral paresthesia
Postmarketing reports: Abdominal pain[Ref]

Respiratory

Common (1% to 10%): Sneezing
Uncommon (0.1% to 1%): Throat irritation[Ref]

Hematologic

Common (1% to 10%): Fibrin D-dimer increased[Ref]

Immunologic

Common (1% to 10%): C-reactive protein increased[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Ocular

Common (1% to 10%): Lipoma

Other

Uncommon (0.1% to 1%): Swelling[Ref]

References

1. "Product Information. Ruconest (conestat alfa)." Valeant Pharmaceuticals, Costa Mesa, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for conestat alfa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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