Rho(d) immune globulin (Injection)

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into a muscle or through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine..

If a dose is missed:

• It is very important that you receive this medicine on a fixed schedule if you are using the medicine for ITP or during pregnancy. If you are unable to keep an appointment for your injection, call your doctor or caregiver for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Introduction

Rho(D) Immune Globulin (roe-dee i-MUNE GLOB-ue-lin)

Given to a pregnant woman whose blood type is Rh-negative to keep the baby's blood from interacting with the mother's. Also treats a blood cell disorder called idiopathic thrombocytopenic purpura (ITP).

Brand Name(s)

Rhophylac, HyperRHO S/D, MICRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, WinRho SDF

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have a history of kidney problems, anemia, blood clotting problems, heart or blood vessel problems (such as atherosclerosis), lung or breathing problems, or have had a stroke.
• 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 vaccine. 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.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, shaking chills, fever, or shortness of breath.
• Black, bloody, or tarry stools.
• Bloody or darkened urine.
• Chest pain, shortness of breath, or coughing up blood.
• Decrease in how much or how often you urinate.
• Fast, slow, pounding, or uneven heartbeat.
• Lightheadedness, dizziness, or fainting.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Pinpoint red spots on the skin.
• Rapid weight gain.
• Sudden or severe headache, or problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, or vomiting.
• Headache.
• Joint or muscle pain.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Rash or itching skin.
• Sleepiness or unusual drowsiness.
• Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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