BayRho-D

BayRHo-D is part of the drug class:

• Specific immunoglobulins

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

Geriatric

Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell 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 used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, severe or
• Blood clotting problems, history of or
• Breathing problems, severe or
• Disseminated intravascular coagulation (blood clotting problem) or
• Kidney problems or
• Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or
• Heart or blood vessel problems or
• Hyperviscosity (thick blood), history of or
• Stroke—Use with caution. May cause side effects to become worse.

• Autoimmune hemolytic anemia (bleeding problem) or
• Hemolysis, active (red blood cells are being destroyed) or
• 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 will not work properly if maltose is 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 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.

Applies to rho (d) immune globulin: injectable, powder for solution, solution

Along with its needed effects, rho (d) immune globulin (the active ingredient contained in BayRHo-D) 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 while taking rho (d) immune globulin:

• 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 of rho (d) immune globulin 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

Rhophylac(R): 250 international units (50 mcg) per kg, IV, at 2 mL per 15 to 60 seconds
WinRho(R):
-Initial dose: 250 international units (50 mcg) per kg, IV, over 3 to 5 minutes; may be divided into 2 doses on separate days if desired.
-Maintenance dose: 125 to 300 international units/kg (25 to 60 mcg/kg), IV, over 3 to 5 minutes

Use: Immune thrombocytopenic purpura (ITP):
-Raising platelet counts in Rho (D)-positive, non-splenectomized acute or chronic ITP

Data not available

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: Not formally assigned to a pregnancy category. US FDA pregnancy category: C Comments: Some formulations are not approved for use during pregnancy. The manufacturer product information should be consulted.

Animal studies have not been conducted. Available evidence does not suggest harm to the fetus or future pregnancies when given to Rho(D) negative women during pregnancy. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Summary of Use during Lactation

Rho(D) immune globulin is a immune globulin (IgG) rich in IgG antibodies against erythrocyte antigen Rho(D). IgG is a normal component of breastmilk. Rho(D) immune globulin is frequently used in nursing mothers and no adverse effects have been reported in breastfed infants. No special precautions are required.

Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1] A flash heating pasteurization reduced decreased the concentration of endogenous immunoglobulin G by 33%.[2] A continuous flow, high-temperature short-time (HTST) pasteurizer at temperatures ranging from 71 to 74 degrees C retained from about 38 to 79% of IgG activity depending on the temperature and exposure time.[3] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG4 retaining all of its activity and IgG1 ans 2 decreasing by about 40 to 50%.[4]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.< br>

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Koenig A, de Albuquerque Diniz EM, Barbosa SF et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439-43. PMID: 16280560

2. Chantry CJ, Israel-Ballard K, Moldoveanu Z et al. Effect of flash-heat treatment on immunoglobulins in breast milk. J Acquir Immune Defic Syndr. 2009;51:264-7. PMID: 19421069

3. Dhar J, Fichtali J, Skura BJ et al. Pasteurization efficiency of a HTST system for human milk. J Food Sci. 1996;61:569-73. DOI: doi:10.1111/j.1365-2621.1996.tb13160.x

4. Rodriguez-Camejo C, Puyol A, Fazio L et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2017. PMID: 28586632

LactMed Record Number

844

Last Revision Date

20170706

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.