Spesolimab

What is Spesolimab?

• Spesolimab (Spevigo) is an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

What are the uses of this medicine?

• Spesolimab (Spevigo) is used to treat generalized pustular psoriasis (GPP) flares in adults.

How does this medicine work?

• Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R.
• Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways.
• The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in Spevigo.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• No formal drug interactions studies have been conducted with spesolimab.

Is this medicine FDA approved?

• It was approved for medical use in the United States in September 2022.
• The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Recommended dosage:

• Administer as a single 900 mg dose by intravenous infusion over 90 minutes.
• If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose.

Administration:

• Your healthcare provider will give you Spevigo through a needle placed in your vein (intravenous infusion) over 90 minutes.
• Spevigo is usually given one time.
• If GPP flare symptoms continue, your healthcare provider will decide if you should receive an additional treatment with Spevigo after 1 week.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Spevigo

What side effects can this medication cause?

The most common side effects of this medicine include:

• feeling tired or weak
• nausea and vomiting
• headache
• itching or itchy bumps
• a collection of blood under the skin at the infusion site or bruising
• urinary tract infection

Less common, but serious side effects may include:

• Infections
• Allergic reactions and infusion-related reactions

What special precautions should I follow?

• Spevigo may increase the risk of infections. Do not initiate Spevigo during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur after treatment with Spevigo.
• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Spevigo. Do not administer Spevigo to patients with active TB infection.
• Hypersensitivity including drug reaction with eosinophilia and systemic symptoms (DRESS) and infusion-related reactions may occur. If a serious hypersensitivity reaction occurs, discontinue Spevigo immediately and initiate appropriate treatment.
• Avoid use of live vaccines in patients treated with Spevigo.
• It is not known if Spevigo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Spevigo.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The limited data on the use of Spevigo in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.
• Human IgG is known to cross the placental barrier; therefore, Spevigo may be transmitted from the mother to the developing fetus.
• It is not known if Spevigo can harm your unborn baby.

Can this medicine be used in children?

• The safety and effectiveness of Spevigo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• spesolimab-sbzo

Inactive ingredients:

• arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, and Water for Injection, USP

Who manufactures and distributes this medicine?

Manufactured by:

• Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA

What should I know about storage and disposal of this medication?

• Must be refrigerated, store at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Prior to use, may store unopened Spevigo vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.

• Dailymed label info on Spesolimab
• FDA Spesolimab

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