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Rhophylac

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF
Rhophylac (Rho(D) immune globulin) prevents an immune response to Rh positive blood in people with an Rh negative blood type. Includes Rhophylac side effects, interactions and indications.
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Drug Information:
Rhophylac contains RHo (D) immune globulin. RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (low red blood cells), kidney failure, or shock. Learn more

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Rhophylac Side Effects

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 Rhophylac.

For the Consumer

Applies to rho (d) immune globulin: solution

Warning

Intravenous route (Powder for Solution; Solution)

Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least 8 hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed.

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

Hematologic

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

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

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

Nervous system

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

Uncommon (0.1% to 1%): Dizziness, vertigo

Gastrointestinal

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

Rare (less than 0.1%): Diarrhea

Cardiovascular

Rare (less than 0.1%): Tachycardia, hypotension

Frequency not reported: Increase in blood pressure

Postmarketing reports: Cardiac arrest, cardiac failure, myocardial infarction

Dermatologic

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

Postmarketing reports: Hyperhidrosis

Musculoskeletal

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

Postmarketing reports: Myalgia, muscle spasm, pain in extremities

Hepatic

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

Postmarketing reports: Jaundice

Hypersensitivity

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

General

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

Respiratory

Rare (less than 0.1%): Dyspnea

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

Renal

Frequency not reported: Acute renal insufficiency

Postmarketing reports: Renal failure, renal impairment

Immunologic

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

Frequency not reported: Sensitization to repeated injections of human globulin

Genitourinary

Postmarketing reports: Hemoglobinuria, anuria, chromaturia, hematuria

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Rhophylac (www.drugs.com/rhophylac.html).