WINRHO SDF Solution for injection (2020)

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Saol Therapeutics Inc.

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1. Indications and Usage

WinRho SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization ...

2. Dosage and Administration

For intravenous or intramuscular use only. 2.1 Dose Treatment of ITP ADMINISTER WinRho SDF BY THE INTRAVENOUS ROUTE ONLY. Proper care should be taken when calculating the dose of WinRho SDF ...

3. Dosage Forms and Strengths

WinRho SDF, Rho(D) Immune Globulin Intravenous (Human), is available as a ready to use solution for injection available in single dose vials of 600 IU (120 mcg), 1,500 IU (300 mcg), 2,500 IU ...

4. Contraindications

WinRho SDF is contraindicated in: Patients who have had known anaphylactic or severe systemic reaction to the administration of human immune globulin products. IgA-deficient patients with antibodies to ...

5. Warnings and Precautions

5.1 Hypersensitivity Severe hypersensitivity reactions may occur [see Contraindications (4)]. If symptoms of allergic or early signs of hypersensitivity reactions (including generalized urticaria, ...

6. Adverse Reactions

Serious adverse reactions, some of these cases resulted in fatal outcome, have been observed in patients receiving WinRho SDF for the treatment of ITP. These include: intravascular hemolysis (IVH), clinically ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under different protocols and widely varying conditions, adverse reaction rates observed in the clinical trials of a specific drug product cannot be directly compared ...

6.2. Postmarketing Experience

The following adverse reactions listed by body system have been identified during the post-approval use of WinRho SDF. Because post-marketing adverse reactions are reported voluntarily from a population ...

7. Drug Interactions

7.1 Live Virus Vaccines Administration of WinRho SDF concomitantly with other drugs has not been evaluated. Passive transfer of antibodies may transiently impair the immune response to live attenuated ...

8.1. Pregnancy

Risk Summary For the treatment of ITP, there is no human data or animal data available to establish the presence or absence of drug-associated risk. When administered to pregnant women in a clinical trial ...

8.2. Lactation

Risk Summary There is no information regarding the presence of WinRho SDF in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of ...

8.4. Pediatric Use

The safety and effectiveness of WinRho SDF has been evaluated for the treatment of chronic or acute ITP in children and in children (<16 years of age) with ITP secondary to HIV infection [see Adverse ...

8.5. Geriatric Use

8.5 Geriatric Use Clinical studies of WinRho SDF did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Post marketing clinical ...

10. Overdosage

Treatment of ITP and Suppression of Rh Isoimmunization In post-marketing spontaneous reporting, there has been a limited number of medication error reports related to dosage calculations in which higher ...

11. Description

WinRho SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen (D antigen). WinRho SDF is to be administered intravenously for the treatment of ITP ...

12.1. Mechanism of Action

Treatment of ITP WinRho SDF has been shown to increase platelet counts in non-splenectomized, Rho(D)-positive patients with ITP. Platelet counts usually rise within one to two days and peak ...

12.2. Pharmacodynamics

In a clinical study with Rho(D)-negative volunteers (nine males and one female), Rho(D)-positive RBCs were completely cleared from the circulation within 8 hours of intravenous administration ...

12.3. Pharmacokinetics

IM versus IV Administration (Lyophilized Powder) In a clinical study involving Rho(D)-negative volunteers, two subjects received 600 IU (120 mcg) WinRho SDF by intravenous (IV) administration ...

14. Clinical Studies

14.1 Treatment of ITP Efficacy was documented in four subgroups of patients with ITP: Childhood Chronic ITP In an open-label, single arm, multicenter study, 24 non-splenectomized, Rho ...

15. References

Provan D, et al.: International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 2010; 115:168-186. Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra ...

16.1. How Supplied

WinRho SDF is available in packages containing: NDC Number Product Description 70257-312-51 A carton containing a single dose vial of 600 IU (120 mcg) anti-Rho(D) IGIV and a package ...

16.2. Storage and Handling

Store at 2 to 8°C (36 to 46°F) Do not freeze Do not use after expiration date Protect from light

17. Patient Counseling Information

Information for Patients See FDA-Approved Patient Labeling ITP and Suppression of Rh IsoimmunizationInform patients of the early signs of hypersensitivity reactions to WinRho SDF including ...