MicRhogam Ultra-Filtered (Injection, Intramuscular, Intravenous)

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

The Rh factor is a component of red blood cells. A person can have either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will produce antibodies that can destroy red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby's blood can enter her system and cause her to produce antibodies. If the same woman has a second baby with Rh-positive blood, the antibodies can destroy the baby's red blood cells. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent antibody formation.

This medicine must be given only by or under the supervision of your doctor.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown specific problems in children that would limit the use of Rho(D) immune globulin. However, it is not recommended for infants with Rh-positive blood if their mother is Rh-negative.

Geriatric

While studies on age-related effects of Rho(D) immune globulin have not been done in older adults, there are no expected geriatric-specific problems that would limit its usefulness. However, older patients are more likely to have heart, kidney, or liver issues related to age, which may require a dose adjustment for those receiving Rho(D) immune globulin.

Breast Feeding

Research suggests that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if there could be an interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical problems, especially:

• Severe anemia
• History of blood clotting problems
• Severe breathing problems
• Disseminated intravascular coagulation (blood clotting problem)
• Kidney problems
• History of pulmonary edema (fluid in the lungs)—Use with caution. May worsen these conditions.

• History of atherosclerosis (hardening of the arteries)
• Heart or blood vessel problems
• History of hyperviscosity (thick blood)
• Stroke—Use with caution. May worsen side effects.

• Autoimmune hemolytic anemia (bleeding problem)
• Active hemolysis (destruction of red blood cells)
• 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 may not work correctly if maltose is present in the blood. Discuss this with your doctor.

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

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:

• Solution

Therapeutic Class: Immune Serum

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.