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Dosage

  • Pregnancy
    Routine antepartum prevention; postpartum prevention
    1500 IU (300 mcg)
  • Other Obstetric conditions*
    Complications; invasive procedures
    1500 IU (300 mcg)
  • Incompatible blood transfusions
    100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentration

*Please see Prescribing Information for a complete list of obstetric conditions for which Rhophylac® is indicated and for additional information on dosage and administration.

Rhophylac® comes in a single box or a 10 pack with each syringe containing a guaranteed 300-mcg dose for either IV or IM administration. IV administration may be more comfortable and convenient for use in the hospital in women who already have IV lines in place. For even more convenience, Rhophylac® has a three-year shelf life from date of manufacture—the longest of any anti-D product.

Administration

View video showing Rhophylac® administration

IV:
To use Rhophylac®, break off the top of the syringe, which will fit your needleless IV tubings. Simply attach it to the tubing and administer the dose as a slow IV push. If the patient requires more than one syringe, consider waiting two hours between administrations. If you use an IV tubing system that is not compatible with the Rhophylac® syringe, call CSL Behring at 800-655-3396 to request a shipment of adaptors at no cost. (See FAQs for more information about using an adaptor with the Rhophylac® syringe and other IV systems.)

IM:
Connect the syringe to the needle and administer the dose into the muscle. For additional safety after administering the dose, Rhophylac® offers a safety glide shielding needle with a one-hand convenient covering of the needle following injection, to reduce the chance of needle-stick accidents. To optimize the IM injection, Rhophylac® uses a
1 1/2-inch 21 gauge needle to ensure that the dose reaches the muscle. Additionally, our needle can be changed to fit the size of the patient.

For more information on dosage and administration, see Prescribing Information.

Important Safety Information

Rhophylac® is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rho(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
  • Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.

For suppression of Rh isoimmunization, Rhophylac® can be administered IM or IV.

Rhophylac® is indicated to raise platelet counts in Rho(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac® must be administered IV.

Rhophylac® is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products.

Allergic or hypersensitivity reactions may occur with Rhophylac®; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

Rhophylac® is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Suppression of Rh Isoimmunization: For postpartum use following an Rh-incompatible pregnancy, Rhophylac® should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac® are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rho(D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac® should be monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hemoglobinuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis has also been observed. In patients with preexisting anemia, weigh the benefits of Rhophylac® against the potential risk of increasing the severity of the anemia.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.