Indications for: LYUMJEV

Diabetes mellitus.

Adults and Children:

<1yr: not established. ≥1yrs: Individualize. For SC inj (Lyumjev U-100 or U-200): give at the start of a meal or within 20mins after starting a meal; use with intermediate or long-acting insulin. Rotate inj sites (abdomen, thigh, upper arm, buttocks). For continuous SC infusion pump (Lyumjev U-100 only): administer into a region as recommended from pump manufacturer; rotate infusion sites (within the same region); change Lyumjev in the reservoir at least every 9 days, the infusion sets, and insertion site accordingly; see full labeling. For IV inj (Lyumjev U-100 only): dilute to conc. of 1 Unit/mL; give only under medical supervision; closely monitor blood glucose and potassium.

LYUMJEV Contraindications:

During episodes of hypoglycemia.

LYUMJEV Warnings/Precautions:

Instruct patients on proper administration of insulin, check insulin label before each injection, and management of hypoglycemia. Do not share pens or cartridges between patients, or needles and syringes when using vials, even if the needle is changed. Visual impairment: will need assistance with prefilled pens. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Increased risk of hyper- or hypoglycemia if changes in physical activity, meal patterns, concomitant medications, renal or hepatic function, insulin regimen, administration site, and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Discontinue if hypersensitivity reactions occur. Insulin pump device malfunction: may cause hyperglycemia, ketoacidosis; have interim SC inj or alternative insulin therapy available. Pregnancy. Nursing mothers.

LYUMJEV Interactions:

Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Potentiated by oral antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, salicylates, somatostatin analogs (eg, octreotide), sulfonamide antibiotics. Antagonized by atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetics, thyroid hormones. Variable effects with β-blockers, clonidine, lithium salts, alcohol, pentamidine. Concomitant β-blockers, clonidine, guanethidine, or reserpine may blunt hypoglycemia; monitor. Do not mix with any other insulin.

Adverse Reactions:

Hypoglycemia, injection/infusion site reactions, allergic reactions, rash, pruritus, lipodystrophy, weight gain, peripheral edema; hypokalemia.

Generic Drug Availability:


How Supplied:

Lyumjev U-100: multiple-dose vials (10mL)—1; single-patient-use (cartridges [3mL], KwikPen [3mL], Junior KwikPen [3mL], Tempo Pen [3mL])—5; Lyumjev U-200: KwikPen (3mL)—2