Pronunciation:

roe-dee i-MUNE GLOB-ue-lin

Brand Names:

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

Dosage Forms:

• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby's blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

This medicine is to be administered only by or under the supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

Older adults—

Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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:

• Anemia, severe or
• Blood clotting problems, history of or
• Breathing problems, severe or
• Disseminated intravascular coagulation (blood clotting problem) or
• Kidney problems or
• Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or
• Heart or blood vessel problems or
• Hyperviscosity (thick blood), history of or
• Stroke—Use with caution. May cause side effects to become worse.

• Autoimmune hemolytic anemia (bleeding problem) or
• Hemolysis, active (red blood cells are being destroyed) or
• Immunoglobulin A (IgA) deficiency with antibodies against IgA—Should not be used in patients with these conditions.

• Diabetes—The liquid form of WinRho® contains maltose. Some glucose testing systems will not work properly if maltose is in the blood. Discuss this with your doctor.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have back pain; shaking chills; a fever; dark urine; a decreased amount of urine; a sudden weight gain; swelling of the hands or feet; or shortness of breath after receiving this medicine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.

While you are being treated with Rho(D) immune globulin, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving Rho(D) immune globulin.

Side Effects of This Medicine:

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.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 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

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.