Medically reviewed by Drugs.com. Last updated on Dec 10, 2019.
Applies to the following strengths: 189 mg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Porphyria
2.5 mg/kg subcutaneously once a month
-Dosing is based on actual body weight.
-Administration should be performed by a healthcare professional.
Use: For the treatment of acute hepatic porphyria (AHP).
Renal Dose Adjustments
No adjustment recommended; monitoring recommended
Liver Dose Adjustments
Interrupt or discontinue treatment for severe or clinically significant transaminase elevations
-In patient who have subsequent improvement of transaminase: Reduce dose to 1.25 mg/kg once a month
-For patients who resume dosing at 1.25 mg/kg once monthly without recurrence of severe or clinically significant transaminase elevations: Dose may be increased to 2.5 mg/kg once a month
-Known severe hypersensitivity to the active substance; reactions have included anaphylaxis
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Healthcare professional should administer via subcutaneous injection once a month
-During administration, adequate medical support to manage an anaphylactic reaction should be readily available
-Administer subcutaneously into abdomen, back or side of the upper arms, or thighs
-Rotate injection sites
-Do not inject into scar tissue or areas that are reddened, inflamed, or swollen
Missed dose: Administer as soon as possible after the missed dose; resume dosing at monthly intervals following administration of the missed dose
-Store at 2C to 25C (35F to 77F); store in original container until ready to use
-Available as a ready-to-use single-dose vial that does not require additional reconstitution or dilution
-Withdraw calculated injection volume using a 21-gauge or larger needle
-Divide doses requiring volumes greater than 1.5 mL equally into multiple syringes
-For injection, use a 25-gauge or 27-gauge needle with 1/2-inch or 5/8-inch needle length
-On average, patients with acute hepatic porphyria (AHP) experienced 70% fewer porphyria attacks compared to placebo patients in clinical trials.
-Monitor for signs and symptoms of anaphylaxis
-Monitor renal function as clinically indicated
-Obtain baseline liver function tests and repeat monthly for the first 6 months, then as clinically indicated
-Patients should understand the risk and symptoms of anaphylaxis that may occur with treatment.
-Patients should be informed about the potential for injection site reactions.
More about givosiran
- Side Effects
- During Pregnancy
- Drug Interactions
- En Español
- Drug class: miscellaneous metabolic agents
Other brands: Givlaari