Xeljanz - Consent Form

CHINTAN MODI, MD.

Please correct the errors described below.

Intro: Tofacitinib inhibits Janus kinase (JAK) enzymes, which are intracellular enzymes involved in stimulating hematopoiesis and immune cell function through a signaling pathway in turn reduces circulating CD16/56+ natural killer cells, serum IgG, IgM, IgA, and C-reactive protein, and increases B cells.

Side effects: (these are the most common)

  • Infection: Infection (20% to 22%)
  • Nasopharyngitis (3% to 14%)
  • Skin rash (6%), acne vulgaris (≥2%)
  • Increased serum cholesterol (7%)
  • Diarrhea, gastroenteritis, nausea (4%)
  • Urinary tract infection (2%)
  • Anemia (4%)
  • Herpes zoster infection (5%)
  • Increased creatine phosphokinase (5%)
  • Increased serum creatinine (<2%)
  • Upper respiratory tract infection (5%)

Other rare side effects
Peripheral edema, Fatigue, insomnia, paresthesia, Erythema, pruritus, Dehydration, Abdominal pain, diverticulitis and appendicitis, vomiting, Malignant lymphoma, skin carcinoma (nonmelanoma), Increased liver enzymes, liver steatosis, Arthralgia, joint swelling, tendinopathy, Cough, dyspnea, interstitial pulmonary disease, paranasal sinus congestion. Angioedema, arterial thrombosis, BK virus, cellulitis, cryptococcosis, cytomegalovirus disease, deep vein thrombosis, esophageal candidiasis, gastric carcinoma, gastrointestinal perforation, hepatotoxicity, histoplasmosis, hypersensitivity reaction, infection due to an organism in genus pneumocystis, listeriosis, lung carcinoma, lymphocytopenia, lymphocytosis, malignant neoplasm of breast, malignant neoplasm of colon or rectum, mycobacterium infection, neutropenia, pancreatic adenocarcinoma, pneumonia, prostate carcinoma, pulmonary embolism, reactivation of HBV, renal cell carcinoma, thrombosis tuberculosis, urticaria.

Need follow ups:

  • Office visit every 3 months is required along with periodic CBC and CMP
  • PPD/Chest X-ray before Rx, Hepatitis B/C test
  • Pneumonia vaccine every 5 years and yearly flu shot
  • Annual skin exam looking for any precancerous lesions on the skin.

I understand that xeljanz has potential side effects and because of this close monitoring of blood counts and follow ups are required. I have been explained the risks, and given opportunity to ask questions. Risks of the active disease outweigh the risks of the medications. I understand and agree to start the medication.

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