teriparatide

(redirected from Teriparatide acetate)

teriparatide (recombinant)

Forsteo, Forteo

Pharmacologic class: Biosynthetic fragment of human parathyroid hormone

Therapeutic class: Parathyroid hormone

Pregnancy risk category C

FDA Box Warning

In male and female rats, drug increased incidence of osteosarcoma (malignant bone tumor). Because of uncertain relevance of this finding to humans, use drug only in patients for whom potential benefits outweigh potential risk. Don't administer to patient at increased baseline risk for osteosarcoma.

Action

Stimulates new bone growth by binding to specific high-affinity cell-surface receptors

Availability

Injection: Multidose prefilled delivery device (pen) with 28 daily doses of 20 mcg/dose (600 mcg/2.4 ml)

Indications and dosages

Osteoporosis in patients at high risk for bone fracture

Adults: 20 mcg/day subcutaneously for up to 2 years

Contraindications

• Hypersensitivity to drug

• Conditions that increase osteosarcoma risk (such as Paget's disease, unexplained alkaline phosphatase elevation, open epiphyses, skeletal radiation therapy)

• Bone cancer metastases or history of bone cancer

• Metabolic bone disease other than osteoporosis

• Hypercalcemia

Precautions

Use cautiously in:

• urolithiasis, hypotension

• concurrent use of cardiac glycosides

• pregnant or breastfeeding patients.

Administration

• Inject subcutaneously into thigh or abdominal wall, with patient lying down.

• Know that prefilled injection pen delivers 20 mcg of drug per actuation and may be reused for up to 28 days after first injection. Discard pen in protected container after 28 days, even if it's not empty.

Adverse reactions

CNS: dizziness, headache, insomnia, depression, vertigo, asthenia

CV: hypertension, angina, syncope

EENT: rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, dyspepsia, anorexia

Metabolic: hyperuricemia

Musculoskeletal: joint pain, cramps

Respiratory: cough, dyspnea, pneumonia

Skin: rash, sweating

Other: pain

Interactions

Drug-drug. Digoxin: increased digoxin toxicity

Drug-diagnostic tests. Calcium: increased level

Patient monitoring

• Monitor respiratory and neurologic status and assess patient's mood.

• Monitor bone mineral density tests and calcium level.

Patient teaching

• Instruct patient to promptly report such adverse reactions as cough and difficulty breathing.

• Tell patient that prefilled injection pen delivers 20 mcg of drug per actuation. Inform him that he may reuse it for up to 28 days after first injection, and should then discard it in appropriate receptacle, even if it's not empty.

• Advise patient to establish effective bedtime routine to minimize insomnia.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects strength and balance.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

teriparatide

(tĕr′ə-păr′ə-tīd′)
n.
A recombinant human parathyroid hormone analog used in the treatment of osteoporosis.

teriparatide

A drug used to treat advanced OSTEOPOROSIS. Teriparatide consists of fragments of parathyroid hormone produced by recombinant DNA technology. These preferentially stimulate osteoblasts over osteoclasts thus increasing new bone formation. The drug is given by subcutaneous injection via a pre-filled pen injector.
References in periodicals archive ?
(Dong-A ST), obtained approval on November 13, 2015, from Korea s Ministry of Food and Drug Safety (MFDS) for the sale of Teribone osteoporosis drug (generic name: teriparatide acetate; product name in Japan: Teribone 56.5 og subcutaneous injection) for the treatment of osteoporosis in postmenopausal women at high risk of bone fracture.
Tokyo, Dec 6, 2011 - (JCN) - Asahi Kasei Pharma has announced the availability of a 56.5µg subcutaneous injection formulation of Teribone (generic name: teriparatide acetate) for the indication of osteoporosis with high risk of fracture, upon listing in the NHI Drug Price Standard.
11 October 2011 - US Zosano Pharma Inc and Japanese Asahi Kasei Pharma Corporation, or AKP, part of Asahi Kasei Corporation (TYO:3407), said on Monday they have signed a long-term strategic partnership deal for the development, commercialisation and supply of a weekly transdermal patch formulation of Teribone (teriparatide acetate), AKP's formulation of human parathyroid hormone (human PTH 1-34), for the treatment of osteoporosis patients with a high risk of fracture.
Asahi Kasei's MN-10-T (generic name Teriparatide acetate, tentative product name Teribone) is aimed at osteoporosis with high risk of fracture (tentative).