Etanercept
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etanercept (ee tah ner' sept) Enbrel Pregnancy Category B Drug classes
Antiarthritic Disease-modifying antirheumatic drug (DMARD) Therapeutic actions
Genetically engineered tumor necrosis factor receptors from Chinese hamster ovary cells; keep inflammatory response to autoimmune disease in check by reacting with and deactivating free-floating tumor necrosis factor released by active leukocytes. Indications
•
• • • •
Reduction of the signs and symptoms of moderately to severely active rheumatoid arthritis; to delay the structural damage associated with rheumatoid arthritis, or may be used in combination with methotrexate when patients do not respond to methotrexate alone Polyarticular-course juvenile rheumatoid arthritis in patients who have not had an adequate response to one or more antirheumatic drugs Reduction of signs and symptoms of psoriatic arthritis; may be used alone or in combination with methotrexate Treatment of ankylosing spondylitis Treatment of psoriatic arthritis
Contraindications and cautions
• •
Contraindicated with allergy to etanercept or Chinese hamster products, lactation, pregnancy, cancer, severe infection including sepsis, CNS demyelinating disorders, myelosuppression. Use cautiously with renal or hepatic disorders, any infection, CHF.
Available forms
Powder for injection—25 mg Dosages ADULTS
25 mg SC twice weekly with 72–96 hr between doses or 50 mg SC once weekly. PEDIATRIC PATIENTS
< 4 yr: Safety and efficacy not established. 4–17 yr: 0.4 mg/kg SC twice weekly with 72–96 hr between doses to a max 25 mg/dose or 0.8 mg/kg SC once weekly. Pharmacokinetics Route SC
Onset Slow
Peak 72 hr
Metabolism: Tissue; T1/2: 115 hr Distribution: Crosses placenta; may enter breast milk Excretion: Tissues Adverse effects
• • • • •
CNS: CNS demyelinating disorders (multiple sclerosis, myelitis, optic neuritis) GI: Abdominal pain, dyspepsia Hematologic: Pancytopenia Respiratory: URIs, congestion, rhinitis, cough, pharyngitis Other: Irritation at injection site; increased risk of infections, cancers; ANA development; headache; autoimmune diseases
Nursing considerations Assessment
• •
History: Allergy to etanercept or Chinese hamster products; pregnancy, lactation; serious infections; cancer; CNS demyelinating disorders, myelosuppression Physical: Skin lesions, color; R, adventitious sounds; injection site evaluation; ROM to monitor drug effectiveness; CNS—neurologic evaluation, reflexes; CBC
Interventions
• • • •
• • • • • •
Obtain a baseline and periodic CBC; discontinue drug at signs of severe bone marrow suppression. Obtain baseline values of neurologic function; discontinue drug at any sign of CNS demyelinating disorders. Advise patient that this drug does not cure the disease and appropriate therapies for rheumatoid arthritis should be used. Reconstitute for injection by slowly injecting 1 mL sterile bacteriostatic water provided with powder into the vial; swirl gently, do not shake; avoid foaming; liquid should be clear and free of particulate matter; use within 6 hr of reconstitution. Do not mix with any other medications. Rotate injection sites between abdomen, thigh, and upper arm. Maintain a chart to ensure that sites are rotated regularly. Teach patient and a significant other how to reconstitute and administer SC injections; observe the process periodically. Monitor patient for any sign of infection; discontinue drug if infection occurs. Evaluate drug effectiveness periodically; 1–2 wk may be required before any change is noted; if no response has occurred within 3 mo, discontinue drug. Do not administer drug with any vaccinations; allow at least 2–3 wk between starting this drug and a vaccination. Protect patient from exposure to infections and ensure routine physical examinations and monitoring for potential cancers and autoimmune diseases.
Teaching points
•
• •
•
Take this drug exactly as prescribed. Note that this drug does not cure rheumatoid arthritis and appropriate therapies to deal with the disease should be followed. You and a significant other should learn how to prepare the drug and to administer SC injections. Prepare a chart of injection sites to ensure that sites are rotated on a regular basis. Consult with your health care provider about proper disposal of needles and syringes. Arrange for frequent, regular medical follow-up, including blood tests to follow the effects of the drug on your body. These side effects may occur: Signs and symptoms of upper respiratory infections, cough, sore throat (consult with your health care provider for potential treatment if this becomes severe); headache (analgesics may be available to help); increased susceptibility to infections (avoid crowded areas and people who might have infections; use strict handwashing and good hygiene). Report fever, chills, lethargy; rash, difficulty breathing; swelling; worsening of arthritis; severe diarrhea.
Adverse effects in Italic are most common; those in Bold are life-threatening.
Antiarthritic Disease-modifying antirheumatic drug (DMARD) Therapeutic actions
Genetically engineered tumor necrosis factor receptors from Chinese hamster ovary cells; keep inflammatory response to autoimmune disease in check by reacting with and deactivating free-floating tumor necrosis factor released by active leukocytes. Indications
•
• • • •
Reduction of the signs and symptoms of moderately to severely active rheumatoid arthritis; to delay the structural damage associated with rheumatoid arthritis, or may be used in combination with methotrexate when patients do not respond to methotrexate alone Polyarticular-course juvenile rheumatoid arthritis in patients who have not had an adequate response to one or more antirheumatic drugs Reduction of signs and symptoms of psoriatic arthritis; may be used alone or in combination with methotrexate Treatment of ankylosing spondylitis Treatment of psoriatic arthritis
Contraindications and cautions
• •
Contraindicated with allergy to etanercept or Chinese hamster products, lactation, pregnancy, cancer, severe infection including sepsis, CNS demyelinating disorders, myelosuppression. Use cautiously with renal or hepatic disorders, any infection, CHF.
Available forms
Powder for injection—25 mg Dosages ADULTS
25 mg SC twice weekly with 72–96 hr between doses or 50 mg SC once weekly. PEDIATRIC PATIENTS
< 4 yr: Safety and efficacy not established. 4–17 yr: 0.4 mg/kg SC twice weekly with 72–96 hr between doses to a max 25 mg/dose or 0.8 mg/kg SC once weekly. Pharmacokinetics Route SC
Onset Slow
Peak 72 hr
Metabolism: Tissue; T1/2: 115 hr Distribution: Crosses placenta; may enter breast milk Excretion: Tissues Adverse effects
• • • • •
CNS: CNS demyelinating disorders (multiple sclerosis, myelitis, optic neuritis) GI: Abdominal pain, dyspepsia Hematologic: Pancytopenia Respiratory: URIs, congestion, rhinitis, cough, pharyngitis Other: Irritation at injection site; increased risk of infections, cancers; ANA development; headache; autoimmune diseases
Nursing considerations Assessment
• •
History: Allergy to etanercept or Chinese hamster products; pregnancy, lactation; serious infections; cancer; CNS demyelinating disorders, myelosuppression Physical: Skin lesions, color; R, adventitious sounds; injection site evaluation; ROM to monitor drug effectiveness; CNS—neurologic evaluation, reflexes; CBC
Interventions
• • • •
• • • • • •
Obtain a baseline and periodic CBC; discontinue drug at signs of severe bone marrow suppression. Obtain baseline values of neurologic function; discontinue drug at any sign of CNS demyelinating disorders. Advise patient that this drug does not cure the disease and appropriate therapies for rheumatoid arthritis should be used. Reconstitute for injection by slowly injecting 1 mL sterile bacteriostatic water provided with powder into the vial; swirl gently, do not shake; avoid foaming; liquid should be clear and free of particulate matter; use within 6 hr of reconstitution. Do not mix with any other medications. Rotate injection sites between abdomen, thigh, and upper arm. Maintain a chart to ensure that sites are rotated regularly. Teach patient and a significant other how to reconstitute and administer SC injections; observe the process periodically. Monitor patient for any sign of infection; discontinue drug if infection occurs. Evaluate drug effectiveness periodically; 1–2 wk may be required before any change is noted; if no response has occurred within 3 mo, discontinue drug. Do not administer drug with any vaccinations; allow at least 2–3 wk between starting this drug and a vaccination. Protect patient from exposure to infections and ensure routine physical examinations and monitoring for potential cancers and autoimmune diseases.
Teaching points
•
• •
•
Take this drug exactly as prescribed. Note that this drug does not cure rheumatoid arthritis and appropriate therapies to deal with the disease should be followed. You and a significant other should learn how to prepare the drug and to administer SC injections. Prepare a chart of injection sites to ensure that sites are rotated on a regular basis. Consult with your health care provider about proper disposal of needles and syringes. Arrange for frequent, regular medical follow-up, including blood tests to follow the effects of the drug on your body. These side effects may occur: Signs and symptoms of upper respiratory infections, cough, sore throat (consult with your health care provider for potential treatment if this becomes severe); headache (analgesics may be available to help); increased susceptibility to infections (avoid crowded areas and people who might have infections; use strict handwashing and good hygiene). Report fever, chills, lethargy; rash, difficulty breathing; swelling; worsening of arthritis; severe diarrhea.
Adverse effects in Italic are most common; those in Bold are life-threatening.
