tofacitinib
tofacitinib
(toe-fa-sye-ti-nib) tofacitinib,Xeljanz
(trade name)Classification
Therapeutic: antirheumaticsPharmacologic: kinase inhibitors
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (clinical improvement)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO | within 2 wk | 3 mo | unknown |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- fatigue
- headache
- insomnia
Cardiovascular
- peripheral edema
Gastrointestinal
- gastric perforation (life-threatening)
- abdominal pain
- diarrhea
- dyspepsia
- gastritis
- ↑ liver enzymes
- vomiting
Genitourinary
- ↑ serum creatinine
Dermatologic
- erythema
- pruritus
- rash
Fluid and Electrolyte
- dehydration
Metabolic
- ↑ lipids
Musculoskeletal
- arthralgia
- joint swelling
- musculoskeletal pain
- tendonitis
Neurologic
- paresthesia
Miscellaneous
- serious infections including tuberculosis, invasive fungal infections, bacterial, viral, and other infections due to opportunistic pathogens
- ↑ risk of malignancy
- fever
Interactions
Drug-Drug interaction
May ↑ risk of adverse reactions and ↓ antibody response to live vaccines (avoid concurrent use).Blood levels and effects may be ↑ by strong CYP3A4 inhibitors including ketoconazole or moderate CYP3A4 inhibitors/strong CYP2C19 inhibitors including fluconazole ; dose ↓ recommended.Blood levels and effectiveness may be ↓ strong CYP3A4 inducers including rifampin.↑ risk of immunosuppression when used concurrently with other potent immunosuppressants including azathioprine, cyclosporine, tacrolimus, antineoplastics or radiation therapy.Route/Dosage
Renal Impairment
Oral (Adults) Moderate to severe renal impairment—5 mg once daily.Hepatic Impairment
Oral (Adults) Moderate hepatic impairment—5 mg once daily.Availability
Nursing implications
Nursing assessment
- Assess pain and range of motion before and periodically during therapy.
- Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis, prior to and periodically during therapy. Tofacitinib is contraindicated in patients with active infection. New infections should be monitored closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections. Infections may be fatal, especially in patients taking immunosuppressive therapy.
- Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dypsnea, 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 tofacitinib until the infection has been diagnosed and adequately treated.
- Lab Test Considerations: Monitor CBC prior to and periodically during therapy. Do not initiate tofacitinib in patients with lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3, or who have hemoglobin level <9 g/dL.
- Monitor lymphocyte count at baseline and every 3 mo thereafter. If lymphocyte count ≥500 cells/mm3 maintain dose. If lymphocyte count <500 cells/mm3and confirmed by repeat testing, discontinue tofacitinib.
- Monitor neutrophil count at baseline, after 4–8 wks of therapy, and every 3 mo thereafter. If ANC >1000 cells/mm3, maintain dose. If ANC 500–1000 cells/mm3, for persistent decreases in this range, interrupt dosing until ANC is >1000 cells/mm3. If ANC <500 cells/mm3 and confirmed by repeat testing, discontinue tofacitinib.
- Monitor hemoglobin at baseline, after 4–8 wks of therapy, and every 3 mo thereafter. If hemoglobin ≤2 g/dL decrease and ≥9.0 g/dL and confirmed by repeat testing, maintain dose. If hemoglobin >2 dL decrease and <8.0 g/dL, interrupt administration of tofacitinib until hemoglobin values have normalized.
- Monitor liver enzymes prior to and periodically during therapy.
- Monitor total cholesterol, LDL cholesterol, HDL cholesterol 4–8 wks following initiation of therapy.
Potential Nursing Diagnoses
Impaired physical mobility (Indications)Risk for infection (Adverse Reactions)
Implementation
- Administer a tuberculin skin test prior to administration of tofacitinib. Patients with active latent TB should be treated for TB prior to therapy.
- Immunizations should be current prior to initiating therapy. Patients on tofacitinib should not receive live vaccines.
- Oral: Administer twice daily without regard to food.
Patient/Family Teaching
- Instruct patient to take tofacitinib as directed. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
- Caution patient to notify health care professional immediately if signs of infection (fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red, or painful skin or sores, diarrhea or stomach pain, burning on urination or urinating more often than normal, feeling very tired) or stomach or intestinal perforation (fever, stomach-area pain that does not go away, change in bowel habits) occur.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
- Inform patient of increased risk of lymphoma and other cancers.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage patient to contact the pregnancy registry by calling 1-877-311-8972 if pregnant.
- Emphasize the importance of follow-up lab tests to monitor for adverse reactions.
Evaluation/Desired Outcomes
- Decreased pain and swelling with improved physical functioning and decreased rate of joint destruction in patients with rheumatoid arthritis.