Public Policy

Two New Inhaled Insulin Products

Another Inhaled Option

Novo Nordisk received initial FDA approval for its long-acting, basal insulin analog—insulin detemir—on June 17, 2005. Subsequent approval for use in the pediatric population came on October 20, 2005. Levemir is expected on U.S. pharmacy shelves any day. Levemir has been approved in 53 countries worldwide, and has been available in Europe since March 2004.

Levemir is a basal insulin, similar to Lantus (glargine, Sanofi-Aventis), and is approved for use in adults with Types 1 and 2 diabetes and in children with Type 1 diabetes.

It is recommended that Levemir be dosed once- or twice-daily subcutaneously. Pharmacokinetically Levemir has a relatively flat action profile with a mean duration of action ranging between 5.7–23.2 hours (data from clinical trials). Following subcutaneous administration, insulin detemir has a slower, more prolonged absorption over 24 hours compared with NPH insulin. Maximum serum concentrations occur within six to eight hours following administration.

A common side effect of insulin therapies is hypoglycemia. Other side effects common to human insulins include allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. A beneficial effect obtained in some of the Levemir clinical studies was weight loss (0.2 to 0.3-kg), which occurred in several Type 1 patients. Comparatively, the Type 1 patients who received NPH insulin noted weight gain (0.4 to 1.4-kg) over the six-12 month timeframe.

There are no specific monitoring parameters for insulin detemir, except for general management of the diabetic patient (e.g., fasting blood sugar, glycosylated hemoglobin, eye exam, podiatry).

At its launch, insulin detemir will be available in 10mL vials as well as in the Levemir FlexPen. The FlexPen will require the use of NovoFine 30- or 31-gauge disposable needles. TH

Michele Kaufman is based in New York City.

References—Exubera

  • Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with Type 2 diabetes: Results of a 6-month, randomized, comparative trial. Diabetes Care. 2004;27:2356-2362.
  • Skyler JS, Weinstock RS, Raskin P, et al. The Inhaled Insulin Phase III Type 1 Diabetes Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in Type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care. 2005 Jul:28(7):1630-1635.
  • Rosenstock J, Zinman B, Murphy LJ, et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 Diabetes—a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):549-588.
  • The Pink Sheet, February 14, 2006; Volume 68, Number 7.Available at www.fda.gov/bbs/topics/news/2006/NEW01304.html. Last accessed March 8, 2006.

References—Levemir

  • Levemir (insulin detemir [rDNA origin] injection) package insert. Novo Nordisk, Inc. Princeton, NJ; October 2005.
  • Goldman JD, Lee KW. Insulin detemir—a new basal insulin analog. nn Pharmacother. 2005;39:502-507.
  • Home P, Bartley P, Russell-Jones D, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes—a randomized clinical trial. Diabetes Care. 2004;27:1081-1087. Available at http://press.novonordisk-us.com/internal.aspx?rid=318. Last accessed March 1, 2006.

Fast Pharma Updates

New Warnings

Elidel cream (pimecrolimus, Novartis) and Protopic ointment (tacrolimus, Astellas—formerly Fujisawa):

New Dosage Form

Zegerid capsules (omeprazole/sodium bicarbonate, Santarus):

  • The only immediate-release proton-pump inhibitor (PPI) capsule available;
  • Other dosage forms include: powder for oral suspension in doses of 20- and 40-mg (cartons of 30). The powder packets are to be administered as a suspension or for nasogastric (NG) or orogastric (OG) use (stop enteral feedings ~3 hours before and one hour after Zegerid administration);
  • FDA-approved for the short-term treatment of active duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, and for the maintenance of healing of erosive esophagitis;
  • Dosing and administration: Take on an empty stomach at least one hour prior to a meal;
  • It has a unique pharmacokinetic profile compared to other PPIs: plasma levels are rapidly reached within ~30 minutes. A median 24-hour pH >4 from ~12 to 18 hours depending on the formulation and dose (data from seven-day repeat dosing clinical trials) used;
  • Due to the formulation with sodium bicarbonate, carefully administer it to patients that must limit their sodium intake. The capsules contain 300-mg of sodium/dose and Zegerid packets contain 460-mg sodium/dose;
  • A Zegerid chewable tablet in 20- and 40-mg doses is currently pending at the FDA;
  • The benefits of Zegerid capsules over other available PPIs is not clearly evident; and
  • Additional information at:

New Indication

Rituxan injection (rituximab, Genentech/Biogen) received FDA-approval on March 1, 2006, for the treatment of adult patients with active rheumatoid arthritis (RA). Other FDA-approved indications for rituximab include: 1) For the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin’s lymphoma, and 2) for the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens.

Rituxan is available in 100-mg and 500-mg sterile, preservative-free, single use vials, and is administered by intravenous infusion. Rituximab is also marketed in Europe under the name MabThera.

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