Osteotide Injection

Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. …

• Recommended dosage is 20 mcg subcutaneously once a day Consider supplemental calcium and Vitamin D based on individual patient needs Administer as a subcutaneous injection into the thigh or abdominal region Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur Use of Teriparatide injection for more than 2 years during a patient’s lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture Recommended Dosage The recommended dosage is 20 mcg per dose given subcutaneously once a day
• Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate
• Administration Instructions Administer Teriparatide injection as a subcutaneous injection into the thigh or abdominal region.Teriparatide injection is not approved for intravenous or intramuscular use
• Teriparatide injection should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions ]
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (Teriparatide injection is a clear and colorless liquid)
• Do not use if solid particles appear or if the solution is cloudy or colored. …

Injection: 560 mcg/2.24 mL (250 mcg/mL) clear, colorless solution in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg. Injection: 560 mcg/2.24 mL (250 mcg/mL) in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg ( 3 )

• The safety and effectiveness of Teriparatide injection have not been established
• In pediatric patients
• Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see Warnings and Precautions ]

Of the patients who received Teriparatide injection in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. Of the patients who received Teriparatide injection in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide and the User Manual) before starting Teriparatide injection and each time the prescription is renewed
• Failure to follow the instructions may result in inaccurate dosing
• Osteosarcoma Patients should be made aware that in rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor)
• Although cases of osteosarcoma have been reported in patients using Teriparatide injection no increased risk of osteosarcoma was observed in adult humans treated with Teriparatide injection [see Warnings and Precautions ]. …

• Teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients
• Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ]
• Patients with hypersensitivity to teriparatide or to any of its excipients

Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.5 , 7.1 ) 7.1 Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide injection may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when Teriparatide injection is used in patients receiving digoxin [see Warnings and Precaution ( 5.5 ) and Clinical Pharmacology ( 12.3 )].

Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget’s disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.1 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification. …

Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 )To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary There are no available data on Teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Teriparatide injection when pregnancy is recognized. …

In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the Teriparatide injection prefilled delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported. Additional signs, symptoms, and complications of Teriparatide injection overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache. …

Store Teriparatide injection under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.