GIVLAARI Solution for injection Ref.[9931] Active ingredients: Givosiran

2.1 Recommended Dosage

The recommended dose of GIVLAARI is 2.5 mg/kg administered via subcutaneous injection once monthly. Dosing is based on actual body weight.

Missed Dose

Administer GIVLAARI as soon as possible after a missed dose. Resume dosing at monthly intervals following administration of the missed dose.

Dose Modification for Adverse Reactions

In patients with severe or clinically significant transaminase elevations, who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly [see Warnings and Precautions (5.2)]. In patients who resume dosing at 1.25 mg/kg once monthly without recurrence of severe or clinically significant transaminase elevations, the dose may be increased to the recommended dose of 2.5 mg/kg once monthly.

2.2 Administration Instructions

Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI [see Warnings and Precautions (5.1)].

GIVLAARI is intended for subcutaneous use by a healthcare professional only.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GIVLAARI is a sterile, preservative-free, clear, colorless-to-yellow solution. It is supplied in a single-dose vial, as a ready-to-use solution that does not require additional reconstitution or dilution prior to administration.

Use aseptic technique.

• Calculate the required volume of GIVLAARI based on the recommended weight-based dosage [see Dosage and Administration (2.1)].
• Withdraw the indicated injection volume of GIVLAARI using a 21-gauge or larger needle.
  • Divide doses requiring volumes greater than 1.5 mL equally into multiple syringes.
• Replace the 21-gauge or larger needle with either a 25-gauge or 27-gauge needle with 1/2" or 5/8" needle length.
• Avoid having GIVLAARI on the needle tip until the needle is in the subcutaneous space.
• Administer injection into the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. An injection should never be given into scar tissue or areas that are reddened, inflamed, or swollen.
  • If injecting into the abdomen, avoid a 5 cm diameter circle around the navel.
  • If more than one injection is needed for a single dose of GIVLAARI, the injection sites should be at least 2 cm apart from previous injection locations.
• Discard unused portion of the drug.

Store at 2°C to 25°C (36°F to 77°F).

Store GIVLAARI in its original container until ready for use.