RhoGAM Ultra-Filtered Plus

Generic Name: rho(d) immune globulin (Intravenous route, Intramuscular route, Injection route)

roe (D) im-MYOON GLOB-yoo-lin

Commonly used brand name(s):

In the U.S.

• BayRho-D
• HyperRHO S/D
• MicRhogam Ultra-Filtered
• Rhogam
• RhoGAM Ultra-Filtered Plus
• Rhophylac
• WinRho SDF

In Canada

• Winrho SDF

Available Dosage Forms:

• Powder for Solution
• Solution
• Injectable

Therapeutic Class: Immune Serum

Uses For RhoGAM Ultra-Filtered Plus

Rh o(D) immune globulin is used to prevent your body from interacting with any of your baby's blood that may get into your blood system while you are pregnant or during the delivery of your baby. If your blood type is Rh o(D) negative and your baby's blood type is Rh o(D) positive, your body may produce a defense (antibodies) against Rh o(D) positive blood. These antibodies usually will not cause a problem if this is your first pregnancy, unless you have had a blood transfusion in the past and have already developed these antibodies. However, if you have other Rh o(D) positive babies in the future, these antibodies may try to destroy the blood of the future babies. If this occurs, it is a very serious condition. Babies born with this condition may need to have their blood replaced.

Rh o(D) immune globulin can be used to treat immune thrombocytopenic purpura, a type of blood disorder. This medicine may be helpful to prevent excessive bleeding.

Rh o(D) immune globulin may also be used if you have recently received a transfusion that contained Rh o(D) positive blood and your blood type is Rh o(D) negative.

Rh o(D) immune globulin is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using RhoGAM Ultra-Filtered Plus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of Rh o(D) immune globulin in children with use in other age groups.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Varicella Virus Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immunoglobulin A (IgA) deficiencies—Rh o(D) immune globulin may cause an allergic reaction to occur
• Rh o(D) positive patients with immune thrombocytopenic purpura, ITP (a type of blood disorder)—Should be monitored for anemia and kidney problems

Proper Use of rho(d) immune globulin

This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to RhoGAM Ultra-Filtered Plus. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • To prevent your body from producing antibodies against Rh o(D) positive blood:
    • Adults and children—One or more injections, depending on how much Rh o(D) positive blood has gotten into your blood system. The medicine may be used during your pregnancy, within 72 hours after your baby is born, at the end of an incomplete pregnancy (abortion, miscarriage), or after a transfusion. The medicine is usually injected into a muscle, although it may be injected into a vein.
  • To help prevent excessive bleeding in patients with immune thrombocytopenic purpura, ITP (a type of blood disorder):
    • Adults and children—One or more injections, depending on factors in your blood. The medicine is injected into a vein.

RhoGAM Ultra-Filtered Plus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Some side effects 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:

• Fever
• soreness at the place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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