Rho (D) Immune Globulin, Injection

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KEY POINTS

• This medicine is given by injection to prevent an immune response to Rh positive blood in pregnant women. This medicine may also be given to treat idiopathic thrombocytopenic purpura.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a severe, life-threatening reaction in people with idiopathic thrombocytopenic purpura. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immune serum globulin

Generic and brand names: HyperRHO S/D; MICRhoGAM; Rho (D) immune globulin, injection; Rho (D) immune serum globulin, injection; RhoGAM; Rhophylac; Win RhoSDF

What is this medicine used for?

This medicine is given by IV (slow drip through a needle into a vein) or by injection (shot) to prevent an immune response to Rh positive blood in pregnant women with Rh negative blood type. This medicine may also be given to treat a blood disease called idiopathic thrombocytopenic purpura (ITP).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or immune globulin, or to latex
• Bleeding problems, a blood disorder, or blood clots
• Diabetes
• Immunoglobulin A deficiency
• Heart attack, stroke, atherosclerosis, or other heart disease
• High levels of triglycerides in your blood
• Kidney disease
• Lupus
• Myeloma
• Problems with dehydration
• Problems with too much protein or abnormal proteins in the blood
• Surgery to remove your spleen

Tell your healthcare provider if you have recently had an infection, or a long period of bed rest, such as after major surgery or a broken bone in a cast.

Tell your healthcare provider about all the medicines you are taking. While receiving this medicine, some medicines may increase your risk of serious side effects, such blood clots or kidney problems.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

These injections are given by your healthcare provider. They may be given while you are in a hospital or clinic.

You may need to have more than one injection over a period of time. Be sure to have the recommended number of shots on schedule.

What should I watch out for?

This medicine may cause a severe, life-threatening reaction in people with idiopathic thrombocytopenic purpura (ITP). You will be closely monitored for at least 8 hours after you receive this medicine. If you have back pain, dark or discolored (such as pink) urine, fever, chills, shaking, urinating less often, sudden weight gain, explained swelling, and shortness of breath, contact your healthcare provider right away.

You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

You may feel tenderness, pain, or muscle stiffness where you had the shot. Contact your healthcare provider if these symptoms do not improve after several hours.

This medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

If you have diabetes: This medicine may affect blood sugar test results. Talk to your healthcare provider before you change your diet or dosage of diabetes medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; fever; chills; nausea; vomiting; chest tightness; trouble breathing; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; chest pain; rapid or irregular heart rate; fainting; severe back pain; severe shaking chills; fever; unusual urine color (such as pink); dark urine; yellowing of skin or eyes; severe nausea or vomiting; problems urinating or urinating less often; unexplained swelling in hands, ankles, feet, or legs; shortness of breath; blue lips, fingers, or feet; sudden weight gain; pain, warmth, redness, or a lump in your legs or arms.

Other: Tenderness, pain, or redness where the shot was given; headache; joint or muscle pain; tiredness; flushing; sweating; stomach cramps; nausea; vomiting; diarrhea; dizziness; itching; rash; mild fever.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Estrogen hormones such as conjugated estrogens (Premarin), esterified estrogens (Estratab, Menest), estradiol (Climara, Estrace, Estraderm, Vivelle), and estropipate (Ogen)

Check with your healthcare provider before having any live-virus vaccines (such as shots for shingles, measles, mumps, and rubella). This medicine may interfere with your response to vaccines for up to 6 months or longer after receiving this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.