Needle-Free Connector Compatibility

Rhophylac is supplied in a standard 2 mL, pre-filled glass syringe. Not every needle-free IV system is compatible with standard glass syringes. IV systems with connectors containing an internal spike, such as the CLAVE® System, can block the fluid path through the syringe and are not compatible with the Rhophylac glass syringe.

(CLAVE is a registered trademark of ICU Medical Inc.)

The following needle-free connector does not contain an internal spike and was tested and found compatible with the Rhophylac syringe:

SAFSITE® from B. Braun is a needle-free connector that was tested and proven compatible for use with Rhophylac syringes by CSL Behring. The following link provides instructions for how to use the SAFSITE needle-free IV system.

Other CSL-tested and compatible needle-free connectors

  • BD PosiFlow™ and BD Q-Syte™ from Becton Dickinson
  • Clearlink from Baxter
  • SmartSite® and SmartSite® Positive Bolus Needle-Free Valve from Alaris / Cardinal Health
  • SWAN-LOCK® from Codan
  • V-LINK Luer Activated Device (with VITALSHIELD) from Baxter
  • Flolink Positive Displacement Device from Baxter

If you have any questions on any of the needle-free connectors, please speak with the manufacturer directly. CSL Behring does not recommend the use of any one particular needle-free connector.

Home About Rhophylac Needle-Free Connector
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Important Safety Information

Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), 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. Consider IV administration if reaching the muscle is of concern.

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.

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rho(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have also been reported. Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products. Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to Rhophylac or any of its components. Do not administer Rhophylac to the newborn infant of a mother who received Rhophylac postpartum.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

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: The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac (≥0.5% of patients) 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 alerted to and monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hematuria. 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 (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of anemia.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella.

Please see full prescribing information for Rhophylac.

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.


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Rhophylac is a registered trademark of CSL Behring Ag. Other trademarks mentioned are property of their respective owners.

CSL Behring
© 2017 CSL Behring. The product information presented on this site is intended for US residents only. RHO13-09-0017 3/2014