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Gamulin Rh Side Effects

Generic Name: rho (d) immune globulin

Note: This document contains side effect information about rho (d) immune globulin. Some of the dosage forms listed on this page may not apply to the brand name Gamulin Rh.

For the Consumer

Applies to rho (d) immune globulin: injectable, powder for solution, solution

Along with its needed effects, rho (d) immune globulin (the active ingredient contained in Gamulin Rh) 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 rho (d) immune globulin:

Rare

  • Bloody urine
  • decreased frequency of urination or amount of urine
  • fever
  • increased blood pressure
  • increased thirst
  • loss of appetite
  • lower back pain
  • nausea or vomiting
  • pale skin
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain

Some side effects of rho (d) immune globulin 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:

Less Common

  • Soreness at the place of injection

For Healthcare Professionals

Applies to rho (d) immune globulin: injectable powder for injection, injectable solution, intramuscular powder for injection, intramuscular solution

Other

Very common (10% or more): Chills (34.7%), pyrexia/increased body temperature (32.6%)

Uncommon (0.1% to 1%): Malaise

Very rare (less than 0.01%): Death

Frequency not reported: Shivering, weakness

Postmarketing reports: Chest pain, fatigue, edema[Ref]

Hematologic

Hemolytic reaction includes hypotension, nausea, chills, headache, and a decrease in haptoglobin and hemoglobin.[Ref]

Very rare (less than 0.01%): Disseminated intravascular coagulation

Frequency not reported: Intravascular hemolysis, hemolysis resulting in death, clinically compromising anemia, extravascular hemolysis, hemolytic reaction

Postmarketing reports: Hemoglobinemia, disseminated intravascular coagulation[Ref]

Local

Uncommon (0.1% to 1%): Injection site swelling, injection site pain

Rare (less than 0.1%): Injection site erythema, injection site induration, injection site warmth, injection site pruritus, injection site rash[Ref]

Nervous system

Very common (10% or more): Headache (14.3%)

Uncommon (0.1% to 1%): Dizziness, vertigo[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea, vomiting

Rare (less than 0.1%): Diarrhea[Ref]

Cardiovascular

Rare (less than 0.1%): Tachycardia, hypotension

Frequency not reported: Increase in blood pressure

Postmarketing reports: Cardiac arrest, cardiac failure, myocardial infarction[Ref]

Dermatologic

Uncommon (0.1% to 1%): Skin reaction, erythema, pruritus, pallor, rash

Postmarketing reports: Hyperhidrosis[Ref]

Musculoskeletal

Rare (less than 0.1%): Arthralgia, back pain

Postmarketing reports: Myalgia, muscle spasm, pain in extremities[Ref]

Hepatic

Very common (10% or more): Increase in blood bilirubin (21.4%)

Postmarketing reports: Jaundice[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity, anaphylactic shock, anaphylactic reaction[Ref]

General

The most common adverse events were chills, pyrexia, increased bilirubin, and headache.[Ref]

Respiratory

Rare (less than 0.1%): Dyspnea

Postmarketing reports: Acute respiratory distress syndrome, transfusion related acute lung injury[Ref]

Renal

Frequency not reported: Acute renal insufficiency

Postmarketing reports: Renal failure, renal impairment[Ref]

Immunologic

Uncommon (0.1% to 1%): Transient positive anti-C antibody test

Frequency not reported: Sensitization to repeated injections of human globulin[Ref]

Genitourinary

Postmarketing reports: Hemoglobinuria, anuria, chromaturia, hematuria[Ref]

References

1. "Product Information. RhoGAM Ultra-Filtered Plus (RHo (D) immune globulin)." Kedrion Biopharma Inc, Cambridge, MA.

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. WinRho SDF (RHo (D) immune globulin)." Nabi, Boca Raton, FL.

5. "Product Information. HyperRHO S/D Full Dose (RHo (D) immune globulin)." Talecris Biotherapeutics, Research Triangle Park, NC.

6. "Product Information. Rhophylac (RHo (D) immune globulin)." ZLB Bioplasma Inc, Glendale, CA.

7. "Product Information. BayRHo-D (RHo (D) immune globulin)." Bayer, West Haven, CT.

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.

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