Q: Does Rhophylac® contain thimerosal or mercury?
Q: Is Rhophylac® a generic form of RhoGAM®?
Q: Is Rhophylac® AB rated?
Q: Will Rhophylac® cause more pain on injection due to the volume and needle length?
Q: Can Rhophylac® be administered with vaccines?
Q: In what other countries is Rhophylac® used?
Q: What if the Rhophylac® syringe is not compatible with my IV system?
Q: Is Rhophylac® available as a micro-dose?
Q: When was Rhophylac® approved by the FDA?
Q: Which distributors stock Rhophylac®?
Q: Are the Rhophylac® syringes bar-coded for inventory purposes?
Q. What is the shelf life of Rhophylac®?
Q: How is Rhophylac® packaged; in what quantities?
Q: Does Rhophylac® contain thimerosal or mercury?
A. Rhophylac® has never contained thimerosal or mercury and is latex-free.
Q: Is Rhophylac® a generic form of RhoGAM®?
A: No. Unlike RhoGAM®, Rhophylac® has never contained thimerosal (mercury). In addition, Rhophylac® is made with state-of-the-art manufacturing techniques to produce Rh prophylaxis with a guaranteed 300 mcg dose, a 3-step viral safety process, and the purity to be administered either IV or IM.
Q: Is Rhophylac® AB rated?
A: No. The AB rating is a coding system developed by the FDA confirming that a generic product is pharmaceutically and therapeutically equivalent to a branded drug based on bioequivalent studies. Since Rhophylac® is a branded product with distinct clinical benefits, this rating does not apply.
Q: Will Rhophylac® cause more pain on injection due to the volume and needle length?
A: There is no evidence to suggest that a Rhophylac® injection causes more pain than injections of other anti-D products with less volume or shorter needles. In a clinical trial, only 2 women-0.9%-reported pain at the injection site. The 1 1/2-inch needle length allows clinicians to decide the best injection site: buttocks, upper arm, or thigh. In addition, the needle is not permanently attached to the syringe, so the clinician can choose a different length needle.
Q: Can Rhophylac® be administered with vaccines?
A: The prescribing information for Rhophylac® states that the product should not be given concurrently with vaccines. This is true of all Ig products and of IVIG products when larger doses are given. If an Rh-negative pregnant woman received a vaccine along with Rhophylac®, her blood levels should be retested in 3 months to be sure that the titer levels of the vaccine are high enough to be effective.
Q: In what other countries is Rhophylac® used?
A: Rhophylac® is used in many countries throughout the world, including Belgium, Brazil, Denmark, Egypt, England, Finland, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Kuwait, Luxembourg, Mexico, the Netherlands, Norway, Portugal, Sweden, Switzerland, and Syria.
Q: What if the Rhophylac® syringe is not compatible with my IV system?
A: If an adaptor is required, the SAFSITE Needle-free IV System is recommended. Working with the SAFSITE Needle-free IV System is easy. According to the instructions of the IV System manufacturer, close the clamp above the port and/or reset the pump. Swab the top of the port per hospital protocol, then follow these simple instructions:
1. Remove the clear cap from the SAFSITE valve and attach it to the IV port by turning clockwise.
2. Remove the blue end cap from the SAFSITE valve and discard. Be careful not to touch the opening of the SAFSITE valve; alcohol swabbing is not necessary.
3. After removing the white cap from the Rhophylac® syringe, attach it to the SAFSITE valve by turning the syringe until it is firmly seated on the valve.
4. When administration of Rhophylac® is complete, remove the SAFSITE valve from the IV port, discard the valve with the Rhophylac® syringe still attached, and then open the IV clamp and/or restart the pump.
Q: Is Rhophylac® available as a micro-dose?
A: Rhophylac® is not currently available as a micro-dose.
Q: When was Rhophylac® approved by the FDA?
A: Rhophylac® was approved for use in the US in 2004. The product has been used effectively in Europe since 1996 and more than 1.5 million doses have been administered.
Q: Which distributors stock Rhophylac®?
A: See a list of authorized distributors for Rhophylac®.
Q: Are the Rhophylac® syringes bar-coded for inventory purposes?
A: Each package is bar-coded and has the NDC number listed. The enclosed syringe has a peel-off label with the lot number and expiration date to place within hospital nursing records.
Q: What is the shelf life of Rhophylac®?
A: Shelf life from date of manufacture is 36 months-longer than any other currently available anti-D products.
Q: How is Rhophylac® packaged; in what quantities?
A: Rhophylac® comes in a single box containing a 300-mcg dose for IV or IM administration and is also available in a 10-pack. A control card and patient ID card are included in the product packaging. See HOW SUPPLIED in Prescribing Information.