Names and pronunciation
(ser′tue-liz′oo-mab) Cimzia
PDF page 265
Loading InternPractice…
Drug reference
(ser′tue-liz′oo-mab) Cimzia
PDF page 265
Func. class.: GI antiinflammatory antirheumatic Func. class.: Antihistamine (second generation, peripherally selective)
PDF pages 265, 267
Chem. class.: Anti–tissue necrosis factor (anti-TNF) agent Chem. class.: Piperazine, H1-histamine antagonist
PDF pages 265, 267
ACTION: Monoclonal antibody that neutralizes the activity of tumor necrosis factor α (TNF-α) found in Crohn’s dis- ease; decreases infiltration of inflamma- tory cells ACTION: Acts on blood vessels, GI, respiratory system by competing with his- tamine for H1-receptor site; decreases allergic response by blocking pharmaco- logic effects of histamine; minimal anti- cholinergic, sedative action
PDF pages 265, 267
USES: Crohn’s disease (moderate to severe) that has not responded to con- ventional therapy, rheumatoid arthritis (moderate to severe), psoriatic arthritis, ankylosing spondylitis, moderate-severe plaque psoriasis in those that are candi- dates for systemic/phototherapy, nonra- diographic axial spondyloarthritis with signs of inflammation USES: Rhinitis, allergy symptoms, chronic idiopathic urticaria
PDF pages 265, 267
Unlabeled uses: Fistulizing Crohn’s disease Unlabeled uses: Asthma, atopic derma- titis
PDF pages 265, 267
Do not confuse: cetirizine/sertraline/stavudine ZyrTEC/Xanax/Zantac/Zocor/ZyPREXA/ Zerit
PDF page 267
CONTRAINDICATIONS: Influ- enza, IV administration, sepsis, hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, geriatric patients, AIDS, coagu- lopathy, diabetes, fungal infection, heart failure, hepatitis, human antichimeric anti- body, immunosuppression, leukopenia, MS, cancer, neurologic/renal disease, sur- gery, thrombocytopenia, TB, vaccinations CONTRAINDICATIONS: Breast- feeding, newborn or premature infants, hypersensitivity to this product or hydrOXYzine, severe hepatic disease Precautions: Pregnancy, children, geri- atric patients, respiratory disease, angle- closure glaucoma, prostatic hypertrophy, bladder neck obstruction, asthma
PDF pages 265, 266, 267
Black Box Warning: Infection, neoplastic disease in children Black Box Warning: Fungal infection: fever, weight loss, diaphoresis, fatigue, dyspnea; discontinue if infection occurs; do not administer to patients with active infection Black Box Warning: Identify TB, risk for HBV before beginning treatment; TB test should be obtained; if present, TB should be treated prior to certolizumab treatment Hepatitis B virus: Carriers of HBV should be monitored; those at risk for HBV should be evaluated prior to use Black Box Warning: Do not use in chil- dren; lymphoma may occur Black Box Warning: Infection: To re- port immediately increased temperature, trouble breathing, cough or other flulike symptoms • Pregnancy/breastfeeding: Those pregnant should enroll in the Mother to Baby Autoimmune Disease Study (877- 311-8972) (se-teer′i-zeen) All Day Allergy, ZyrTEC, ZyrTEC Children′s Allergy C
PDF pages 266, 267
SIDE EFFECTS CNS: Anxiety, bipolar disorder, suicidal ideation CV: Heart failure, MI, cardiac dysrhythmia, angina, stroke, thrombophlebitis, hyper tension GI: Abdominal pain HEMA: Anemia, pancytopenia INTEG: Rash, urticaria, angioedema MISC: Anaphylaxis, antibody formation, arthralgia, bleeding, infection, lupus-like symptoms, lymphadenopathy, malignan- cies, serum sickness RESP: Upper respiratory tract infection, cough SIDE EFFECTS CNS: Headache, drowsiness, sedation, fatigue EENT: Pharyngitis, dry mouth INTEG: Rash, eczema RESP: Pharyngitis
PDF pages 266, 268
INTERACTIONS • Do not administer live vaccines, tox- oids concurrently Increase: possible infections—abata- cept, adalimumab, anakinra, etanercept, immunosuppressive agents, inFLIXimab, rilonacept; do not use concurrently Increase: immunosuppressant toxicity— pimecrolimus, tofacitinib, tocilzumab INTERACTIONS Increase: CNS depression—alcohol, opi- ates, sedative/hypnotics, other CNS depressants Increase: anticholinergic/sedative effect— MAOIs Drug/Lab Test False negative: skin allergy tests
PDF pages 266, 268
TREATMENT OF OVERDOSE: Administer diazePAM, vasopressors, phe- nytoin IV HIGH ALERT
PDF page 268
DOSAGE AND ROUTES Crohn’s disease (moderate to severe) • Adult: SUBCUT 400 mg given as 2 injections at wk 0, 2, 4; if clinical re- sponse occurs, give 400 mg q4wk RA (moderate to severe)/ankylosing spondylitis/psoriatic arthritis • Adult: SUBCUT 400 mg (as 2 injec- tions of 200 mg) once, then repeat at wk 2 and 4; maintenance, 200 mg q2wk or 400 mg q4wk Moderate-severe plaque psoriasis • Adult: SUBCUT 400 mg (as two 200- mg injections) every other wk • Adult <90 kg: SUBCUT 400 mg (as two 200-mg injections) at wk 0, 2, 4, then 200 mg every other wk DOSAGE AND ROUTES • Adult and child ≥6 yr: PO 5-10 mg/day • Child 2-5 yr: PO 2.5 mg/day, may in- crease to 5 mg/day or 2.5 mg bid • Child 1-2 yr: PO 2.5 mg/day, may in- crease to 2.5 mg q12hr • Geriatric: PO 5 mg/day, may increase to 10 mg/day Renal dose/hemodialysis dose • Adult: PO CCr 11-31 mL/min, 5 mg/day Hepatic dose • Adult: PO 5 mg daily • Child 6-11 yr: PO 2.5 mg daily
PDF pages 266, 267
Available forms: Solution for injection 200 mg/mL; prefilled syringe 400-mg kit Available forms: Tablets 5, 10 mg; syrup 5 mg/5 mL, chewable tablets 5, 10 mg; oral disintegrating tablet 10 mg; capsules 10 mg
PDF pages 266, 267
Administer: SUBCUT route • TB testing: Required prior use, should be done baseline, periodically, use in TB or active infection is contra- indicated • Give by SUBCUT injection only • Reconstitution: Allow to warm to room temperature; add 1 mL sterile water for injection to each vial; 2 vials will be needed for patients with Crohn’s disease • Gently swirl; do not shake; full recon- stitution may take up to 30 min; recon- stituted product may remain at room temperature for up to 2 hr or refriger- ated up to 24 hr • If reconstituted product has been re- frigerated, allow to warm to room tem- perature • Use 2 syringes and two 20G needles • Withdraw reconstituted solution from each vial into separate syringes; each will contain 200 mg; switch 20G to 23G nee- dle; inject into 2 separate sites in abdo- men or thigh • Store in refrigerator; do not freeze Administer: • Without regard to meals • Store in tight, light-resistant container • Chewable tablets: chew before swal- lowing; may use with or without water • Syrup: use calibrated measuring device
PDF pages 266, 268
Assess: • Antinuclear antibody test (ANA), hep- atitis B serology, CBC with differential, blood dyscrasias • Rheumatoid arthritis/ankylosing spon- dylitis: pain, range of motion baseline and during treatment • Crohn’s disease: nausea, vomiting, ab- dominal pain, hepatitis, increased LFTs • CV status: B/P, pulse, chest pain • Allergic reaction, anaphylaxis: rash, dermatitis, urticaria, dyspnea, hypoten- sion, fever, chills; discontinue if severe; administer EPINEPHrine, corticosteroids, antihistamines; assess for allergies to murine proteins prior to starting therapy Assess: • Allergy symptoms: pruritus, urticaria, watering eyes at baseline and during treatment • Respiratory status: rate, rhythm, in- crease in bronchial secretions, wheezing, chest tightness
PDF pages 266, 268
Evaluate: • Therapeutic response: absence of fever, mucus in stools; decreased inflammation in joints, ability to move without pain Evaluate: • Therapeutic response: absence of running or congested nose, rashes
PDF pages 267, 268
CLINICAL CONSIDERATIONS CLINICAL CONSIDERATIONS
PDF pages 266, 268
Patient and caregiver information: • Not to breastfeed while taking this product • To notify prescriber of GI symptoms, hypersensitivity reactions, infections, fluid retention; redness, pain, swelling at injec- tion site • Not to operate machinery, drive if diz- ziness, vertigo occur • Not to receive live virus vaccines while taking this product • How to inject medications if given prefilled syringes for home use • To discuss with provider all OTC, Rx, herbals, supplements taken • To seek emergency services for ana- phylaxis, angioedema, hypersensitivity • To report immediately rash; itching; swollen lips, tongue, face • To discuss possible secondary malig- nancy Patient and caregiver information: • About all aspects of product use; to notify prescriber if confusion, sedation, or hypotension occurs • To avoid driving, other hazardous ac- tivity if drowsiness occurs; to take at night, as drowsiness may occur, especially in children • To avoid alcohol, other CNS depres- sants, OTC antihistamines • To avoid exposure to sunlight; burns may occur • To use sugarless gum, candy, frequent sips of water to minimize dry mouth
PDF pages 267, 268
PHARMACOKINETICS Peak 54-171 hr, half-life 14 days PHARMACOKINETICS Absorption rapid; onset ½ hr; peak 1-2 hr; duration 24 hr; protein binding 93%; half-life 8.3 hr, decreased in chil- dren, increased in renal/hepatic disease
PDF pages 266, 268
• Adult: SUBCUT 400 mg given as 2 injections at wk 0, 2, 4; if clinical re- sponse occurs, give 400 mg q4wk RA (moderate to severe)/ankylosing spondylitis/psoriatic arthritis
PDF pages 266, 267
• Adult: SUBCUT 400 mg (as 2 injec- tions of 200 mg) once, then repeat at wk 2 and 4; maintenance, 200 mg q2wk or 400 mg q4wk Moderate-severe plaque psoriasis
PDF pages 266, 267
• Adult: SUBCUT 400 mg (as two 200- mg injections) every other wk
PDF pages 266, 267
• Adult <90 kg: SUBCUT 400 mg (as two 200-mg injections) at wk 0, 2, 4, then 200 mg every other wk DOSAGE AND ROUTES
PDF pages 266, 267
• Adult and child ≥6 yr: PO 5-10 mg/day
PDF pages 266, 267
• Adult: PO CCr 11-31 mL/min, 5 mg/day Hepatic dose
PDF pages 266, 267
• Adult: PO 5 mg daily
PDF pages 266, 267