Winrho Sdf, Rhophylac

Rho(D) Immune Globulin

(ar aych oh (dee) i MYUN GLOB yoo lin)

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

For people with immune thrombocytopenia (ITP): Some patients with immune thrombocytopenia (ITP) have had a severe reaction with this drug. Sometimes, this has been deadly. Call your doctor right away if you have dark urine, back pain, fever, chills, less urine passed, swelling, sudden weight gain, shortness of breath, dizziness, or shaking. Most of the time, this happened within 4 to 8 hours after a dose. Watch for these effects for 72 hours after getting this drug. Severe kidney problems, anemia, and other blood problems have also happened. If you have questions, talk with the doctor. You will be watched closely by your doctor.

It is used to treat Rh hemolytic disease. It is used to treat immune thrombocytopenia (ITP). It may be given to you for other reasons. Talk with the doctor.

For all patients taking this drug: If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have an allergy to corn or corn products. If you have any of these health problems: Anemia, other blood or bleeding problems, or you have had your spleen removed. If you have IgA deficiency. If you have recently had a live vaccine Children: If your child is a newborn. Some brands of this drug are not for use in newborns. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug. If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use. The chance of blood clots may be raised with this drug. The chance may be higher in older people, if you have to be in a bed or chair for a long time, if you take estrogen products, or if you have certain catheters. Some health problems like thick blood, heart problems, or a history of blood clots raise the chance of having blood clots. Blood clots can happen if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor. Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose. You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. This drug is made from human plasma (part of the blood) and may have viruses that may cause disease. This drug is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor. Do not get any vaccines for 3 months after getting immune globulin without talking with your doctor. If you are 65 or older, use this drug with care. You could have more side effects. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain. Back pain. Stomach pain. Dark urine or yellow skin or eyes. Upset stomach or throwing up. Shortness of breath, a big weight gain, or swelling in the arms or legs. Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak. Pale skin. Shivering. Muscle spasm.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Headache. Feeling dizzy, sleepy, tired, or weak. Pain, redness, or swelling where the shot was given. Diarrhea. Muscle or joint pain. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as a shot.

Call your doctor to find out what to do.

If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.