Getting Patients Started on SYLVANT®

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Important Safety Information
Prescribing Information

Important Safety Information Prescribing Information

Getting Patients Started on SYLVANT®. For your patients with iMCD

Hello , ,

Reaching an idiopathic multicentric Castleman disease (iMCD) diagnosis can be difficult; starting a new patient on SYLVANT^® (siltuximab) should not be.

For appropriate patients taking SYLVANT, Recordati Rare Diseases offers personalized support through its R.A.R.E^® (Recordati Access, Resources, and Engagement) program, designed to make it easier for patients to access and stay on treatment. Scroll down to learn more.

INDICATIONS AND USAGE

SYLVANT^® (siltuximab) is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Limitations of Use
SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.

See below for Important Safety Information.

If insurance doesn’t cover SYLVANT, patients can talk to a R.A.R.E. team member to see if they qualify for financial assistance.

	Benefit Investigation Insurance Specialists provide support by obtaining insurance coverage for medication.
	Co-pay Program R.A.R.E. helps commercially-insured patients get their medication for $5 per infusion. For patients who are not eligible for co-pay support or who need additional financial assistance, R.A.R.E. can provide referrals to other possible sources of funding.*
	Patient Assistance Program Patients who lack insurance and meet certain financial requirements may be eligible for additional financial support from a Patient Assistance Program.*
	Patient Support Patient liaisons help patients by answering questions, providing medication reminders, and supporting them in meeting treatment goals.

Have your patients call the R.A.R.E Patient Support Program

*Restrictions, limitations, and/or eligibility requirements apply.

If insurance doesn’t cover SYLVANT, patients can talk to a R.A.R.E. team member to see if they qualify for financial assistance.

	Benefit Investigation Insurance Specialists provide support by obtaining insurance coverage for medication.
	Co-pay Program R.A.R.E. helps commercially-insured patients get their medication for $5 per infusion. For patients who are not eligible for co-pay support or who need additional financial assistance, R.A.R.E. can provide referrals to other possible sources of funding.*
	Patient Assistance Program Patients who lack insurance and meet certain financial requirements may be eligible for additional financial support from a Patient Assistance Program.*
	Patient Support Patient liaisons help patients by answering questions, providing medication reminders, and supporting them in meeting treatment goals.

*Restrictions, limitations, and/or eligibility requirements apply.

Our Patient Liaison (PL) Program^† offers one‑on‑one support at no cost from Recordati Rare Diseases.

The Patient Liaison will call enrolled patients to:

^†	PL services are provided by Recordati Rare Diseases to help support patients while on SYLVANT therapy. Information provided by the PL Program is for educational purposes only and is not intended to replace the advice of the healthcare provider. This is an opt-in program, which requires enrollment before PL services can be provided.
^‡	PL Program services are available in Spanish.

Our Patient Liaison (PL) Program^† offers one‑on‑one support at no cost from Recordati Rare Diseases.

The Patient Liaison will call enrolled patients to:

Provide education and answer question about iMCD and SYLVANT. Help patients access SYLVANT. Connect patients with other iMCD resources

^†	PL services are provided by Recordati Rare Diseases to help support patients while on SYLVANT therapy. Information provided by the PL Program is for educational purposes only and is not intended to replace the advice of the healthcare provider. This is an opt-in program, which requires enrollment before PL services can be provided.
^‡	PL Program services are available in Spanish.

IMPORTANT SAFETY INFORMATION

SYLVANT is contraindicated in patients experiencing a severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

Concurrent Active Severe Infections: Do not administer SYLVANT to patients with severe infections until the infection resolves. SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute Phase reactants such as C-reactive protein (CRP). Monitor patients receiving SYLVANT closely for infections. Institute prompt anti-infective therapy and do not administer further SYLVANT until the infection resolves.

Vaccinations: Do not administer live vaccines to patients receiving SYLVANT because IL-6 inhibition may interfere with the normal immune response to new antigens.

Infusion Related Reactions and Hypersensitivity:Stop the infusion of SYLVANT if the patient develops signs of anaphylaxis. Discontinue further therapy with SYLVANT.

Stop the infusion if the patient develops a mild to moderate infusion reaction. If the reaction resolves, the SYLVANT infusion may be restarted at a lower infusion rate. Consider medicating with antihistamines, acetaminophen, and corticosteroids. Discontinue SYLVANT if the patient does not tolerate the infusion following these interventions.

Administer SYLVANT in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.

Gastrointestinal (GI) Perforation: Gastrointestinal (GI) perforation has been reported in clinical trials although not in MCD trials. Use with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with symptoms that may be associated or suggestive of GI perforation.

The most common adverse reactions (>10% compared to placebo) in the MCD clinical trial were rash, pruritus, upper respiratory tract infections, increased weight, and hyperuricemia.

Cytochrome P450 Substrates: Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. The effect of SYLVANT on CYP450 enzyme activity can persist for several weeks after stopping therapy. Exercise caution when SYLVANT is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin).

Pregnancy and Lactation: SYLVANT may cause embryo-fetal harm when administered to pregnant women. Advise female patients of reproductive potential to use effective contraception during treatment with SYLVANT and for 3 months after the last dose. Advise females not to breastfeed during treatment with SYLVANT and for 3 months after the final dose.

Dosage and Administration: Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

Before prescribing SYLVANT, please read the full Prescribing Information.

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