Sylvant

Name: Sylvant

Sylvant Dosage

Siltuximab is injected into a vein through an IV. A healthcare provider will give you this injection once every 3 weeks. Follow your doctor's dosing instructions very carefully.

Before each injection, your doctor may perform blood tests to make sure you do not have conditions that would prevent you from safely using siltuximab.

Siltuximab must be given slowly and the IV infusion can take at least 1 hour to complete.

Siltuximab can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your siltuximab treatments may be delayed based on the results of these tests.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your siltuximab injection.

Side Effects of Sylvant

Serious side effects have been reported with Sylvant. See the “Sylvant Precautions” section.

Common side effects of Sylvant include the following:

  • rash
  • itchy skin (pruritis)
  • upper respiratory tract infection
  • weight gain
  • increased blood level of uric acid

This is not a complete list of Sylvant side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

Sylvant Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • medications that use the enzyme CYP450 such as:

    • warfarin (Coumadin, Jantoven)
    • cyclosporine (Neoral, Sandimmune, Gengraf)
    • theophylline
    • lovastatin (Mevacor)
    • atorvastatin (Lipitor)
    • oral contraceptives

This is not a complete list of Sylvant drug interactions. Ask your doctor or pharmacist for more information.

 

Sylvant and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Sylvant crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Sylvant.

 

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your siltuximab injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Sylvant Pharmacokinetics

Absorption

Bioavailability

Pharmacokinetics are approximately dose proportional over the dosage range of 2.8–11 mg/kg every 3 weeks.1

Steady-state concentrations achieved by the sixth infusion (within 18 weeks), resulting in systemic accumulation of approximately 1.7-fold.1

Special Populations

Age (range: 18–85 years) and gender do not affect exposure of siltuximab.1

Distribution

Extent

Crosses the placenta in animals.1

Not known whether distributed into human milk.1

Elimination

Half-life

Mean half-life following first IV infusion: 20.6 days.1

Special Populations

Mild or moderate (Child-Pugh class A or B) hepatic impairment: Clearance similar to patients with normal hepatic function.1

Severe hepatic impairment (Child-Pugh class C): Pharmacokinetics not studied.1

Mild, moderate, or severe (Clcr of 15–89 mL/minute) renal impairment: Clearance similar to patients with normal renal function.1

Actions

  • Binds to human IL-6 and prevents its binding to both soluble and membrane-bound IL-6 receptors.1 2 4 5 13 14 19

  • IL-6 is involved in a variety of normal physiologic processes, including induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and cell proliferation and differentiation.1 2 4 5 13 14 19

  • Overproduction of IL-6 appears to play a critical role in the disease process of MCD,1 4 13 19 resulting in plasma cell proliferation and a variety of systemic manifestations.1 4 14 15 19 (See Multicentric Castleman's Disease [MCD] under Uses.)

  • Cause of MCD in patients who are not infected with HIV and HHV-8 not fully elucidated; however, HHV-8 is a well established cause of hypercytokinemia in HIV-infected and in some HIV-negative patients with the disease.15 16

  • Siltuximab did not bind to virally produced IL-6 in a nonclinical study.1

Advice to Patients

  • Importance of advising patients about potential benefits and risks of siltuximab.1 Importance of patients reading the manufacturer's patient information prior to initiation of therapy and each time they receive an infusion of the drug.1

  • Risk of increased susceptibility to infection.1 Instruct patients to immediately contact their clinician if symptoms suggesting an infection occur to ensure rapid evaluation and appropriate treatment.1

  • Importance of advising patients that they should not receive live vaccines during siltuximab therapy.1 Importance of informing clinician of recent or scheduled vaccinations and of discussing recommended vaccinations with their clinician prior to beginning siltuximab therapy.1

  • Risk of infusion-related and allergic reactions.1 Importance of immediately reporting signs and symptoms of such reactions, including dizziness, lightheadedness, wheezing, swelling of the lips, rash, breathing difficulty, or chest pain or tightness.1

  • Importance of advising patients to report any new or worsening medical conditions to their clinician.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of advising women not to breast-feed during therapy.1 Necessity of advising women of childbearing potential to use effective contraception while receiving siltuximab and for 3 months after the drug is discontinued.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., infections, GI disease).1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

How is this medicine (Sylvant) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some other side effects of Sylvant?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Headache.
  • Feeling tired or weak.
  • Joint pain.
  • Throat pain.
  • Belly pain.
  • Weight gain.
  • Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How Supplied/Storage and Handling

How Supplied

Each Sylvant vial is individually packaged in a carton:

  • NDC 57894-420-01 contains one 100 mg vial, single use vial
  • NDC 57894-421-01 contains one 400 mg vial, single use vial

Storage and Stability

Sylvant must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use Sylvant beyond the expiration date (EXP) located on the carton and the vial.

While stored, protect from light. This product contains no preservative.

Important information

You should not use Sylvant if you have a severe infection. Tell your doctor if you have recently had any signs of infection (fever, chills, body aches).

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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