Spevigo Injection Dosage

Generic name: SPESOLIMAB 60mg in 1mL
Dosage form: injection
Drug class: Interleukin inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 1, 2024.

Testing and Procedures Prior to Treatment Initiation

Evaluate patients for active or latent tuberculosis (TB) infection. SPEVIGO initiation is not recommended in patients with active TB infection. Consider initiating treatment of latent TB prior to initiation of SPEVIGO [see Warnings and Precautions (5.2)].

Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating SPEVIGO for treatment of GPP [see Warnings and Precautions (5.4)].

Important Administration Information

Subcutaneous Use for Treatment of GPP When Not Experiencing a Flare

SPEVIGO prefilled syringes are for subcutaneous use for treatment of GPP when not experiencing a flare.
If required, the 600 mg subcutaneous loading dose of SPEVIGO is to be administered by a healthcare professional [see Dosage and Administration (2.3)].
For subsequent 300 mg doses, if the healthcare professional determines that it is appropriate, a patient 12 years of age and older may self-inject or the caregiver may administer SPEVIGO after proper training in subcutaneous injection technique. In pediatric patients 12 to 17 years of age, administer SPEVIGO under the supervision of an adult.
If a patient experiences a GPP flare while receiving subcutaneous SPEVIGO, the GPP flare may be treated with intravenous SPEVIGO [see Dosage and Administration (2.4)].

Intravenous Use for Treatment of GPP Flare

SPEVIGO vials are for intravenous use for treatment of GPP flare.
Intravenous infusion of SPEVIGO is only to be administered by a healthcare professional in a healthcare setting. Prepare SPEVIGO intravenous infusion by diluting SPEVIGO single-dose vials [see Dosage and Administration (2.5)].
Do not mix SPEVIGO with other medicinal products.

Recommended Subcutaneous Dosage for Treatment of GPP When Not Experiencing a Flare

The recommended dosage of SPEVIGO for treatment of GPP when not experiencing a flare in adults and pediatric patients 12 years of age and older and weighing at least 40 kg is a loading dose of 600 mg (four 150 mg injections) followed by 300 mg (two 150 mg injections) administered subcutaneously 4 weeks later and every 4 weeks thereafter.

Initiating or Reinitiating Subcutaneous SPEVIGO After Treatment of a GPP Flare with Intravenous SPEVIGO

Four weeks after treatment of a GPP flare with intravenous SPEVIGO [see Dosage and Administration (2.4)], initiate or reinitiate subcutaneous SPEVIGO for treatment of GPP at a dose of 300 mg (two 150 mg injections) administered every 4 weeks. A subcutaneous loading dose is not required following treatment of a GPP flare with intravenous SPEVIGO.

Recommended Intravenous Dosage for Treatment of GPP Flare

The recommended dosage of SPEVIGO for treatment of GPP flare in adults and pediatric patients 12 years of age and older and weighing at least 40 kg is a single 900 mg dose administered by intravenous infusion over 90 minutes.

If GPP flare symptoms persist, an additional intravenous 900 mg dose (over 90 minutes) may be administered one week after the initial dose.

Preparation and Administration Instructions

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permits. SPEVIGO is a colorless to slightly brownish-yellow, clear to slightly opalescent solution. Do not use if the solution is cloudy, discolored, or contains large or colored particulates.

Prefilled Syringe (Subcutaneous Use for Treatment of GPP When Not Experiencing a Flare)

Before subcutaneous injection, remove SPEVIGO prefilled syringes from the refrigerator and allow SPEVIGO to reach room temperature (15 to 30 minutes) without removing the needle cap.
Administer SPEVIGO subcutaneously in the upper thighs or abdomen. Do not inject into areas where the skin is tender, bruised, erythematous, indurated, or scarred.
Choose a different injection site for each injection, at least 1 inch away from the other injection sites. Alternate between the upper thigh and abdomen injection sites for each complete dose.
For a complete 300 mg dose, two 150 mg/mL prefilled syringes are required to be injected, one right after the other.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The SPEVIGO "Instructions for Use" contains more detailed instructions on the preparation and administration of SPEVIGO [see Instructions for Use].

Vial (Intravenous Use for Treatment of GPP Flare)

Preparation

SPEVIGO solution for intravenous infusion must be diluted before use.
Use aseptic technique to prepare the solution for infusion.
Draw and discard 15 mL from a 100 mL container of sterile 0.9% Sodium Chloride Injection.
Slowly replace with 15 mL of SPEVIGO (complete content from two vials of 450 mg/7.5 mL).
Mix gently before use.
Use the diluted SPEVIGO solution immediately. If not administered immediately, refrigerate the diluted solution at 2°C to 8°C (36°F to 46°F) for no more than 4 hours. Protect from light.

Administration

Administer SPEVIGO as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes.
A pre-existing intravenous line may be used for administration of SPEVIGO. The line must be flushed with sterile 0.9% Sodium Chloride Injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
If the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes [see Warnings and Precautions (5.3)].
No incompatibilities have been observed between SPEVIGO and infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).