Rhophylac

Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Serious side effects have been reported with Rhophylac including the following:

• Intravascular hemolysis (IVH). IVH is a serious blood problem. Tell your healthcare provider right away if you have some or all of the following symptoms of IVH:
  • back pain
  • shaking chills
  • a fever
  • dark urine
  • a decreased amount of urine
  • a sudden weight gain
  • swelling of the hands or feet
  • shortness of breath
• Allergic reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
  • itching
  • a rash
  • hives
  • chest pain
  • dizziness or lightheadedness
  • trouble breathing
  • any swelling of your hands, face, or mouth

Do not take Rhophylac if you are allergic to Rhophylac or to any of its ingredients.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rhophylac falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Rhophylac should be given to a pregnant woman only if clearly needed.

You should not receive this medicine if you have ever had an allergic reaction to an immune globulin, or if you have:

• immune globulin A (IgA) deficiency with antibody to IgA; or

• hemolytic anemia (a lack of red blood cells).

To make sure RHo (D) immune globulin is safe for you, tell your doctor if you have:

• a history of anemia;

• heart disease or a history of coronary artery disease (hardened arteries);

• a bleeding disorder (such as hemophilia);

• high triglycerides (a type of fat in the blood);

• kidney disease; or

• diabetes.

RHo (D) immune globulin is often used during and after pregnancy. This medicine is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely after you receive immune globulin. Your urine may also need to be tested every 2 to 4 hours for at least 8 hours.

For treatment during pregnancy, this medicine is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medicine is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with RHo (D) immune globulin.

RHo (D) immune globulin can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using this medicine.

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, chills, shaking, back pain, unusual weakness, red or pink urine;

• pale or yellowed skin, dark colored urine;

• rapid breathing, rapid heart rate, confusion, feeling short of breath;

• signs of kidney failure--little or no urinating, swelling, rapid weight gain; or

• signs of a blood clot--sudden numbness or weakness, slurred speech, problems with vision or balance, chest pain, coughing up blood, swelling with redness and warmth in one or both legs.

Common side effects may include:

• nausea, diarrhea, vomiting, stomach pain;

• headache, dizziness;

• drowsiness, weakness, general ill feeling;

• joint or muscle pain;

• flushing (warmth, redness, or tingly feeling);

• mild itching or skin rash;

• increased sweating; or

• pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to 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:

• Powder for Solution
• Solution
• Injectable

Therapeutic Class: Immune Serum

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:

• 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:

• 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.

As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.

Preparation and Handling

• Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.

• Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.

• Do not freeze.

• Bring Rhophylac to room temperature before use.

• Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

Suppression of Rh Isoimmunization

Rhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites.

Table 1 provides dosing guidelines based on the condition being treated.

ITP

For treatment of ITP, ADMINISTER Rhophylac BY THE INTRAVENOUS ROUTE ONLY (see Preparation and Handling [2.1]). Do not administer intramuscularly.

A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:

Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes

Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.

Rhophylac is a sterile Rh0(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh0(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.

Plasma is obtained from healthy Rh0(D)-negative donors who have been immunized with Rh0(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of Rhophylac is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of Rhophylac is tested by FDA-licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. An investigational NAT for HBV is also performed on all source plasma used and found to be negative; however, the significance of a negative result has not been established. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).

Rhophylac is produced by an ion-exchange chromatography isolation procedure4, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. The manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton™ X-100) that is effective in inactivating enveloped viruses such as HIV, HCV, and HBV.5,6 Rhophylac is filtered using a Planova® 15 nanometer (nm) virus filter that has been validated to be effective in removing both enveloped and non-enveloped viruses. Table 3 presents viral clearance and inactivation data from validation studies, expressed as the mean log10 reduction factor (LRF).

Rhophylac contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac has a purity greater than 95% IgG. Rhophylac contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. Rhophylac contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

• Rhophylac 1500 IU (300 mcg) is supplied in packages of one or ten (10) prefilled, ready-to-use, glass syringe(s), each containing 2 mL liquid for injection. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use.
• Rhophylac contains no preservatives.
• The prefilled Rhophylac syringe contains no latex.
• DO NOT FREEZE.
• Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.
• Keep Rhophylac in its original carton to protect it from light.

The following presentations of Rhophylac are available:

You should not receive Rhophylac if you have ever had an allergic reaction to an immune globulin, or if you have:

• immune globulin A (IgA) deficiency with antibody to IgA; or

• hemolytic anemia (a lack of red blood cells).

To make sure Rhophylac is safe for you, tell your doctor if you have:

• a history of anemia;

• heart disease or a history of coronary artery disease (hardened arteries);

• a bleeding disorder (such as hemophilia);

• high triglycerides (a type of fat in the blood);

• kidney disease; or

• diabetes.

Rhophylac is often used during and after pregnancy. This medicine is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving Rhophylac to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Rhophylac is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Rhophylac.