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Zemaira

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Zemaira

Zemaira

Zemaira Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zemaira [Alpha1-Proteinase Inhibitor (Human)] is a protein (alpha 1-antitrypsin) that occurs naturally in the body. In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs). Zemaira is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema. Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and this drug will not cure this condition. This medication may be available in generic form. Common side effects include drowsiness, dizziness, weakness, cough, sore throat, stuffy nose, pain or bleeding where the medication was injected, warmth, redness, or tingly feeling under your skin, nausea, diarrhea, stomach pain, headache, or mild itching.

The recommended dose of Zemaira is 60 mg/kg body weight administered once weekly. Zemaira may interact with other drugs. Tell your doctor all medications and supplements you use. Zemaira may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Zemaira [Alpha1-Proteinase Inhibitor (Human)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zemaira in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

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

  • chest pain, severe headache, buzzing in your ears, uneven heartbeats;
  • fast heart rate;
  • problems with vision; or
  • fever, chills, runny nose, skin rash, and joint pain.

Less serious side effects may include:

  • drowsiness, dizziness, weakness;
  • cough, sore throat, stuffy nose;
  • pain or bleeding where the medication was injected;
  • warmth, redness, or tingly feeling under your skin;
  • nausea, diarrhea, stomach pain;
  • headache; or
  • mild itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zemaira (Alpha-Proteinase Inhibitor (Human)) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zemaira FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Intravenous administration of Zemaira (alpha-proteinase inhibitor (human)) , 60 mg/kg weekly, has been shown to be generally well tolerated. In clinical studies, the following treatment-related adverse reactions were reported: asthenia, injection site pain, dizziness, headache, paresthesia, and pruritus. Each of these related adverse events was observed in 1 of 89 subjects (1%). The adverse reactions were mild.

Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate countermeasures and supportive therapy should be administered.

Table 3 summarizes the adverse event data obtained with single and multiple doses during clinical trials with Zemaira (alpha-proteinase inhibitor (human)) and Prolastin®. No clinically significant differences were detected between the two treatment groups.

Table 3: Summary of Adverse Events

 

Zemaira

Prolastin®

No. of subjects treated

89

32

No. of subjects with adverse events regardless of causality (%)

69 (78%)

20 (63%)

No. of subjects with related adverse events (%)

5 (6%)

4 (13%)

No. of subjects with related serious adverse events

0

0

No. of infusions

1296

160

No. of adverse events regardless of causality (rates per infusion)

298 (0.230)

83 (0.519)

No. of related adverse events (rates per infusion)

6 (0.005)

5 (0.031)

The frequencies of adverse events per infusion that were ≥0.4% in Zemaira (alpha-proteinase inhibitor (human)) -treated subjects, regardless of causality, were: headache (33 events per 1296 infusions, 2.5%), upper respiratory infection (1.6%), sinusitis (1.5%), injection site hemorrhage (0.9%), sore throat (0.9%), bronchitis (0.8%), asthenia (0.6%), fever (0.6%), pain (0.5%), rhinitis (0.5%), bronchospasm (0.5%), chest pain (0.5%), increased cough (0.4%), rash (0.4%), and infection (0.4%). The following adverse events, regardless of causality, occurred at a rate of 0.2% to <0.4% per infusion: abdominal pain, diarrhea, dizziness, ecchymosis, myalgia, pruritus, vasodilation, accidental injury, back pain, dyspepsia, dyspnea, hemorrhage, injection site reaction, lung disorder, migraine, nausea, and paresthesia.

Diffuse interstitial lung disease was noted on a routine chest x-ray of one subject at Week 24. Causality could not be determined.

In a retrospective analysis, during the 10-week blinded portion of the 24-week clinical study, 6 subjects (20%) of the 30 treated with Alpha1-Proteinase Inhibitor (Human), Zemaira (alpha-proteinase inhibitor (human)) had a total of 7 exacerbations of their chronic obstructive pulmonary disease (COPD). Nine subjects (64%) of the 14 treated with Prolastin® had a total of 11 exacerbations of their COPD. The observed difference between groups was 44% (95% confidence interval from 8% to 70%). Over the entire 24-week treatment period, of the 30 subjects in the Zemaira (alpha-proteinase inhibitor (human)) treatment group, 7 subjects (23%) had a total of 11 exacerbations of their COPD.

Read the entire FDA prescribing information for Zemaira (Alpha-Proteinase Inhibitor (Human)) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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