teriparatide

(redirected from AndroGel)
Also found in: Dictionary, Thesaurus, Encyclopedia.

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 ?
Side-by-side comparison of TTh topical products TNG Topical transdermal gel Testosterone per day 22 mg 50 mg androgel (26) (starting dose) 50 mg testim (27) Delivery mechanism Nasal Spread by hand to upper arms applicator /shoulders and/or right and left abdomen Black box warning None Transference risk Applications per day 2 or 3 Time required for a single 10 seconds 8-10 minutes application Includes application, drying and estimated cleanup times required to reduce transference risks Application notes NA Area must be continually covered and/or product removed if skin-to-skin contact with treated area and another person is anticipated Please Note: Illustration(s) are not available due to copyright restrictions.
between 2009 and 2013 were topical preparations such as Androgel, itself the best-selling testosterone product in the United States.
Dobs et al., "Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men," Journal of Clinical Endocrinology and Metabolism, vol.
Solvay filed a New Drug Application for their brand-name drug, AndroGel, in 1999.
Actavis also entered into a copromotion agreement with Solvay, agreeing to promote AndroGel to urologists.
The court also noted that "Watson agreed to promote branded AndroGel to urologists, and Par agreed to promote it to primary care doctors.
In the case of AndroGel, three generic companies were seeking to invalidate the patent held by Solvay Pharmaceuticals, which in turn sued the generic manufacturers.
Testosterone gels that are rubbed into the skin on a daily basis, such as AndroGel or Testim, are another option for replacement therapy.
Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston.
New labeling on two prescription topical testosterone gels, Androgel and Testim, will highlight the risk of adverse effects in children exposed to these products.
Androgen creams (Androgel and Testim) are now available for daily topical use, minimising the peaks and trough side-effects of injectables.
Principio ativo Nome comercial (BR) Nome comercial exterior Cipianato de Deposteron Andryl; Ardoene; Testosterona Delastetryl; Duratestos- Testosterona Androgel terone; Ruathate; Enarmon-depot; Esteres de Durateston;Estrandon Everone; Malogen; testosterona Primoteston Depot; Testosterona Trinestril Tesone; Testanate; Testaval; associada Testosteron Propionato de Tesurene depot; Testoviron- depot testosterona Testosteron -Depot; Texto-Enant.; Undecanoato de Androxon Duratest; Testa-C testosterona Tabela 2--Perfil dos amostrados divididos em relacao ao genero, Joinville, 2008.