e-TAN-er-sept

Therapeutic Classification: antirheumatics (DMARDs)

Pharmacologic Classification: anti tnf agents

• Moderately to severely active rheumatoid arthritis (as monotherapy or in combination with methotrexate).
• Moderate to severely active polyarticular juvenile idiopathic arthritis.
• Active ankylosing spondylitis.
• Psoriatic arthritis (as monotherapy or in combination with methotrexate).
• Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

• Binds to tumor necrosis factor (TNF), making it inactive. TNF is a mediator of inflammatory response.

• Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.
• Reduced severity of plaques.

Absorption: 60% absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 115 hr (range 98–300 hr).

(symptom reduction)

Contraindicated in:

• Hypersensitivity
• Active infection (including localized)
• Untreated infections
• Granulomatosis with polyangiitis (receiving immunosuppressive agents)
• Concurrent cyclophosphamide or anakinra
• Lactation: Lactation.

Use Cautiously in:

• History of chronic or recurrent infection or underlying illness/treatment predisposing to infection (including advanced or poorly controlled diabetes)
• History of exposure to tuberculosis
• History of opportunistic infection
• History of hepatitis B
• Patients residing, or who have resided, where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic
• Pre-existing or recent demyelinating disorders (multiple sclerosis, myelitis, optic neuritis)
• Latex allergy (needle cover of diluent syringe contains latex)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Pedi: Children with significant exposure to varicella virus (temporarily discontinue etanercept; consider varicella zoster immune globulin); ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL]), leukemia, and other malignancies
• Pedi: Safety and effectiveness not established in children <2 yr (juvenile idiopathic arthritis) or <4 yr (plaque psoriasis)
• Geri: Older adults may have ↑ risk of infection.

Derm: psoriasis, rash.

EENT: rhinitis, pharyngitis.

GI: abdominal pain, dyspepsia.

Hemat: pancytopenia.

Local: injection site reactions.

Neuro: headache, dizziness, weakness.

Resp: upper respiratory tract infection, cough, respiratory disorder.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION (INCLUDING REACTIVATION TUBERCULOSIS AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER), SARCOIDOSIS.

Drug-Drug:

• Concurrent use with anakinra ↑ risk of serious infections (not recommended).
• Concurrent use of cyclophosphamide may ↑ risk of malignancies.
• Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
• May ↓ antibody response to live-virus vaccine and ↑ risk of adverse reactions (do not administer concurrently).

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

• SC (Adults): 50 mg once weekly.

Plaque Psoriasis

• SC (Adults): 50 mg twice weekly for 3 mo, then 50 mg once weekly, may also be given as 25–50 mg once weekly as an initial dose.
• SC (Children ≥4 yr and ≥63 kg): 50 mg once weekly.
• SC (Children ≥4 yr and <63 kg): Enbrel: 0.8 mg/kg once weekly.

Juvenile Idiopathic Arthritis

• SC (Children ≥2 yr and ≥63 kg): 50 mg once weekly.
• SC (Children ≥2 yr and <63 kg): 0.8 mg/kg once weekly.

• Powder for injection: 25 mg/vial;
• Solution for injection: 25 mg/0.5 mL (prefilled syringe and single-dose vial); 50 mg/mL (prefilled syringe and autoinjector);

• Assess range of motion, degree of swelling, and pain in affected joints before and periodically during therapy.
• Assess for injection site reaction (erythema, pain, itching, swelling). Reactions are usually mild to moderate and last 3–5 days after injection.
• Monitor patients who develop a new infection while taking etanercept closely. Discontinue therapy in patients who develop a serious infection or sepsis. Do not start etanercept in patients with active infections.
• Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock). Ascertain if patient lives in or has traveled to areas of endemic mycoses. Consider empiric antifungal treatment for patients at risk of histoplasmosis and other invasive fungal infections until the pathogens are identified. Consult with an infectious diseases specialist. Consider stopping etanercept until the infection has been diagnosed and adequately treated.

• Monitor CBC with differential periodically during therapy. May cause leukopenia, neutropenia, thrombocytopenia, and pancytopenia. Discontinue etanercept if symptoms of blood dyscrasias (persistent fever) occur.

• Do not confuse Enbrel with Levbid.
• Administer a tuberculin skin test prior to administration of etanercept. Patients with active latent TB should be treated for TB prior to therapy.
• SC: Prepare injection with single dose prefilled syringe, single-dose vial or multidose vial for reconstitution.
  • Allow solution in prefilled syringe to reach room temperature (15–30 min); do not remove needle cap during this time.
  • For single-dose vial, allow solution to reach room temperature for at least 30 min before injecting. Solution may contain small white particles of protein; do not use if discolored, cloudy, or contains other particulate matter. Discard unused solution. Individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges can also be stored at room temp for up to 30 days.
  • For multidose vial, Reconstitution: reconstitute with 1 mL of the bacteriostatic sterile water supplied by manufacturer for a concentration of 25 mg/mL. If the vial is used for multiple doses, use a 25-gauge needle for reconstituting and withdrawing solution and apply "Mixing Date" sticker with date of reconstitution entered. Inject diluent slowly into vial to avoid foaming. Some foaming will occur. Swirl gently for dissolution; do not shake or vigorously agitate to prevent excess foaming. Solution should be clear and colorless; do not administer solution that is discolored or contains particulate matter. Dissolution usually takes <10 min. Withdraw solution into syringe. Some foam may remain in vial. Amount in syringe should approximate 1 mL. Do not filter reconstituted solution during preparation or administration. Attach a 27-gauge needle to inject. Administer as soon as possible after reconstitution; stable up to 6 hr if refrigerated. Solution and prefilled syringes are stable if refrigerated and used within 14 days.
  • May be injected into abdomen, thigh, or upper arm. Rotate sites. Do not administer within 1 in. of an old site or into area that is tender, red, hard, or bruised.
• Syringe Incompatibility: Do not mix with other solutions or dilute with other diluents.

• Instruct patient on self-administration technique, storage, and disposal of equipment. First injection should be administered under the supervision of health care professional. Provide patient with a puncture-proof container for used equipment. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient not to receive live vaccines during therapy. Parents should be advised that children should complete immunizations to date before starting etanercept. Patients with significant exposure to varicella virus (chickenpox) should temporarily discontinue therapy and varicella immune globulin should be considered.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
• Advise patient that methotrexate, analgesics, NSAIDs, corticosteroids, and salicylates may be continued during therapy.
• Instruct patient to notify health care professional if upper respiratory or other infections occur. Therapy may need to be discontinued if serious infection occurs.
• Advise patient of risk of malignancies such as hepatosplenic T-cell lymphoma. Instruct patient to report signs and symptoms (splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) to health care professional promptly.
• Rep: Instruct females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. Advise patients who become pregnant during therapy to notify health care professional. May limit administration of live vaccines to infant.

• Reduction in symptoms of rheumatoid arthritis. Symptoms may return within 1 mo of discontinuation of therapy.
• Reduced severity of plaques in chronic plaque psoriasis.

Enbrel

Brenzys, Erelzi

NDC Code^*

• 50090- A-S Medication Solutions
  • 50090-3531- ENBREL
    • 50090-3531-0- 1 mL in 1 KIT (50090-3531-0)

• 50090- A-S Medication Solutions
  • 50090-4490- ENBREL
    • 50090-4490-0- 1 mL in 1 KIT (50090-4490-0)

• 58406- Immunex Corporation
  • 58406-010- ENBREL
    • 58406-010-04- 4 SYRINGE in 1 CARTON (58406-010-04) >.5 mL in 1 SYRINGE (58406-010-01)

• 58406- Immunex Corporation
  • 58406-021- ENBREL
    • 58406-021-04- 4 SYRINGE in 1 CARTON (58406-021-04) > 1 mL in 1 SYRINGE (58406-021-01)

• 58406- Immunex Corporation
  • 58406-032- ENBREL
    • 58406-032-04- 4 SYRINGE in 1 CARTON (58406-032-04) > 1 mL in 1 SYRINGE (58406-032-01)

• 58406- Immunex Corporation
  • 58406-044- ENBREL
    • 58406-044-04- 4 CARTRIDGE in 1 CARTON (58406-044-04) > 1 mL in 1 CARTRIDGE (58406-044-01)

• 58406- Immunex Corporation
  • 58406-425- ENBREL
    • 58406-425-34- 4 KIT in 1 CARTON (58406-425-34) > 1 KIT in 1 KIT (58406-425-41) * 1 mL in 1 VIAL (58406-424-01) * 1 mL in 1 SYRINGE (58406-910-01)

• 58406- Immunex Corporation
  • 58406-435- ENBREL
    • 58406-435-04- 4 SYRINGE in 1 CARTON (58406-435-04) > 1 mL in 1 SYRINGE (58406-435-01)

• 58406- Immunex Corporation
  • 58406-445- ENBREL
    • 58406-445-04- 4 SYRINGE in 1 CARTON (58406-445-04) > 1 mL in 1 SYRINGE (58406-445-01)

• 58406- Immunex Corporation
  • 58406-446- ENBREL
    • 58406-446-04- 4 SYRINGE in 1 CARTON (58406-446-04) > 1 mL in 1 SYRINGE (58406-446-01)

• 58406- Immunex Corporation
  • 58406-455- ENBREL
    • 58406-455-04- 4 SYRINGE in 1 CARTON (58406-455-04) >.5 mL in 1 SYRINGE (58406-455-01)

• 58406- Immunex Corporation
  • 58406-456- ENBREL
    • 58406-456-04- 4 CARTRIDGE in 1 CARTON (58406-456-04) > 1 mL in 1 CARTRIDGE (58406-456-01)