Names and pronunciation
(lan′a-del′ue-mab) Takhzyro
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Drug reference
(lan′a-del′ue-mab) Takhzyro
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Func. class.: Complement inhibitors Func. class.: Antiulcer, proton pump inhibitor
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Chem. class.: Plasma kallikrein inhibitor Chem. class.: Benzimidazole
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ACTION A fully human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein and inhibits its proteolytic activity and decreases plasma kallikrein activity to control excess bradykinin gen- eration in patients with HAE ACTION: Suppresses gastric secretion by inhibiting hydrogen/potassium ATPase enzyme system in gastric parietal cell; characterized as gastric acid pump inhib- itor because it blocks the final step of acid production
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USES Prophylaxis to prevent attacks of heredi- tary angioedema (HAE) in those ≥12 L USES: Gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systemic GERD, pathologic hypersecretory conditions (Zollinger- Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas); possibly effective for treatment of duodenal, gastric ulcers, maintenance of healed duo- denal ulcers
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Unlabeled uses: Dyspepsia, stress ulcer prophylaxis in critically-ill patients, GERD (infants/neonates), eosinophilic esophagitis
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CONTRAINDICATIONS Hypersensitivity to this product or poly- sorbate 80 (some preparations) CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, hypomagnesemia, osteoporosis
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SIDE EFFECTS CNS: Headache, dizziness GI: Diarrhea, increased LFTs INTEG: Injection site reaction, rash MS: Myalgia RESP: URI MISC: Antibody development, hypersen sitivity SIDE EFFECTS CNS: Headache, dizziness GI: Diarrhea, abdominal pain, nausea, constipation, flatulence, acid regurgita- tion, anorexia, irritable colon, CDAD GU: Hematuria, glycosuria, impotence, kidney calculus, breast enlargement
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INTERACTIONS Increase: bleeding risk—warfarin Decrease: lansoprazole absorption— sucralfate Decrease: absorption of ketoconazole, itraconazole, iron salts, calcium carbon- ate, atazanavir, ampicillin Increase: hypomagnesemia—loop/thia- zide diuretics Decrease: lansoprazole effect—antimus- carinics, H2-blockers • Avoid use with dasatinib, delavirdine Drug/Herb • Avoid use with red yeast rice, St. John’s wort Drug/Food • Food decreases rate of absorption; use L before food
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DOSAGE AND ROUTES Adult/child ≥12 yr: SUBCUT 300 mg q2wk; consider using q4 wk when attack free for >6 months DOSAGE AND ROUTES Frequent heartburn • Adult: PO (OTC) 15 mg daily up to 14 days Duodenal ulcer (H. pylori eradication) • Adult: PO 15 mg/day before eating for 4 wk, then 15 mg/day to maintain healing of ulcers; associated with Helicobacter pylori: 30 mg lansoprazole bid, 1 g amoxicillin bid; clarithromycin 500 mg bid × 10-14 day or lansoprazole tid with 1 g amoxicillin tid × 14 days Pathologic hypersecretory conditions • Adult: PO 60 mg/day, may give up to 90 mg bid, administer doses of >120 mg/day in divided doses NSAID-related ulcer (continuing use) • Adult: PO 30 mg daily × 8 wk GERD/esophagitis • Adult/adolescent: PO 15-30 mg/day × 8 wk • Child 1-11 yr (>30 kg): PO 30 mg/day ≤12 wk • Child 1-11 yr (≤30 kg): PO 15 mg/day ≤12 wk • Infant (unlabeled): PO 1-1.74 mg/kg/ day; limited data available • Neonate (unlabeled): PO 0.5-1 mg/kg/ day Stress gastric prophylaxis • Adult: NG Use 30 mg del rel caps or 30 mg disintegrating tab once daily
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Available forms: Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose vial Administer • Give SUBCUT only • Provided as a ready-to-use solution in a single-dose vial that does not require ad- ditional reconstitution or dilution for ad- ministration, clear to slightly opalescent, colorless to slightly yellow solution, do not use if discolored or contains visible parti- cles, do not shake • Allow to warm for 15 min after remov- ing from refrigerator • Using aseptic technique, withdraw the prescribed dose using an 18-gauge needle, change the needle on the syringe to a 27-gauge, ½-inch needle or other needle suitable for SUBCUT injection, inject SUB- CUT into the abdomen, thigh, or upper arm • Give within 2 hr of preparing, after sy- ringe is prepared, it can be refrigerated at 36°F to 46°F (2°C to 8°C), use within 8 hr Available forms: Del rel caps 15, 30 mg; orally disintegrating tabs 15, 30 mg
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Administer: PO route • Swallow caps whole 30 min before eating; do not crush or chew caps; caps may be opened and contents sprinkled on food Delayed-release capsules • Swallow intact, do not chew or crush, may be opened and contents sprinkled on 1 Tbsp applesauce or other soft food, swallow immediately; or contents may be mixed into a small volume of juice, mixed and swallowed, rinse with 2 or more oz volume of liquid and have patient take NG route • Oral cap: open cap and pour ¼ of granules into NG feeding syringe with plunger removed, slowly add water and depress plunger, repeat until all granules used; flush tube with 15 mL water • Place on tongue, allow to dissolve, use without regard to water • Oral syringe: dissolve 15 mg/4 mL or 30 mg/10 mL water, use extra water in syringe to remove all of the product NG tube • Oral disintegrating tab: mix 30 mg tab in 10 mL water, give via NG tube, flush tube with 10 mL sterile water, clamp for 60 min
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Assess: • Symptoms of hereditary angioedema (HAE): Swelling of arms, legs, face, intestinal tract, airway, abdominal pain, vomiting, baseline and periodically after treatment • Hypersensitivity: Monitor for allergic reactions Assess: • CDAD: bowel sounds, abdomen for pain, swelling; anorexia, blood in stool; may oc cur even after completion of therapy • Hepatic studies: AST, ALT, alk phos during treatment • INR and prothrombin time when tak- ing warfarin • Magnesium: low magnesium may occur, palpitations, muscle spasm, tremors • Beers: avoid scheduled use for >8 wk unless for high-risk patients (oral corti- costeroids/chronic NSAIDs use) • Pregnancy/breastfeeding: use only if clearly needed; do not breastfeed
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Evaluate: • Therapeutic response • Decreasing swelling of arms, legs, face, intestinal tract, airway, abdominal pain, vomiting Evaluate: • Therapeutic response: absence of epi- gastric pain, swelling, fullness
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CLINICAL CONSIDERATIONS CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report to provider headache, mus- cle pain, diarrhea, severe injection site irritation, fast heartbeat, severe dizziness • Signs of an allergic reaction: rash; itching; red, swollen, blistered, peeling skin; wheez- ing; swelling of the mouth, face, lips, tongue, or throat; notify provider immediately • Provide instructions to patient, care- giver on how to administer product using SUBCUT injection • Pregnancy/breastfeeding: To advise provider if pregnancy is planned or sus- pected or if breastfeeding (lan-so-prey′zole) Prevacid, Prevacid SoluTab Patient and caregiver information: • To report severe diarrhea, cramping, blood in stools, fever; product may have to be discontinued • That hypoglycemia may occur if dia- betic; to monitor blood glucose • To avoid hazardous activities; that diz- ziness may occur • To avoid alcohol, salicylates, ibupro- fen; may cause GI irritation • That if using OTC for heartburn, it may take 1-4 days to see full benefit • Teach patient the reason for use and how to take, to take 30-60 min before eating • Symptoms of low magnesium levels • Pregnancy: to notify provider if preg nancy is planned or suspected or if breastfeeding
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PHARMACOKINETICS Onset unknown, peak 4.11-5.17 days, duration unknown, half-life 14.2-15 days Interactions None known Drug/Lab Increase: aPTT PHARMACOKINETICS Absorption after granules leave stomach 80%; half-life 11⁄2-2 hr; protein binding 97%; extensively metabolized in liver; excreted in urine, feces; clearance decreased in geriatric patients, renal/ hepatic impairment, onset 1-3 hr, peak 1.7 hr duration 24 hr
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• Adult: PO (OTC) 15 mg daily up to 14 days Duodenal ulcer (H. pylori eradication)
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• Adult: PO 15 mg/day before eating for 4 wk, then 15 mg/day to maintain healing of ulcers; associated with Helicobacter pylori: 30 mg lansoprazole bid, 1 g amoxicillin bid; clarithromycin 500 mg bid × 10-14 day or lansoprazole tid with 1 g amoxicillin tid × 14 days Pathologic hypersecretory conditions
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• Adult: PO 60 mg/day, may give up to 90 mg bid, administer doses of >120 mg/day in divided doses NSAID-related ulcer (continuing use)
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• Adult: PO 30 mg daily × 8 wk GERD/esophagitis
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• Adult/adolescent: PO 15-30 mg/day × 8 wk
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• Child 1-11 yr (>30 kg): PO 30 mg/day ≤12 wk
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• Child 1-11 yr (≤30 kg): PO 15 mg/day ≤12 wk
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• Infant (unlabeled): PO 1-1.74 mg/kg/ day; limited data available
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• Neonate (unlabeled): PO 0.5-1 mg/kg/ day Stress gastric prophylaxis
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• Adult: NG Use 30 mg del rel caps or 30 mg disintegrating tab once daily
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