TYMLOS Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Radius Health, Inc.
Λέξεις κλειδιά
70539-001
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WARNINGS SECTION
<b>Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging ...
1. Indications and Usage
TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients ...
2. Dosage and Administration
2.1 Recommended Dosage The recommended dosage of TYMLOS is 80 mcg subcutaneously once daily. Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during ...
3. Dosage Forms and Strengths
Injection: 3120 mcg/1.56 mL (2000 mcg/mL) in a single-patient-use prefilled pen. The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL of a sterile, clear, colorless ...
4. Contraindications
TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea and urticaria ...
5. Warnings and Precautions
5.1 Risk of Osteosarcoma Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure ...
6. Adverse Reactions
The following adverse reactions are described in greater detail in other sections: Orthostatic Hypotension <em>[see Warnings and Precautions (5.2)]</em> Hypercalcemia <em>[see Warnings and Precautions ...
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 ...
6.2. Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...
6.3. Postmarketing Experience
The following adverse reactions have been identified during the post-approval use of TYMLOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
No specific drug-drug interaction studies have been performed <em>[see Clinical Pharmacology (12.3)]</em>.
8.1. Pregnancy
Risk Summary TYMLOS is not indicated for use in females of reproductive potential. There are no human data with TYMLOS use in pregnant women to inform any drug associated risks. Animal reproduction studies ...
8.2. Lactation
Risk Summary TYMLOS is not indicated for use in females of reproductive potential. There is no information on the presence of abaloparatide in human milk, the effects on the breastfed infant, or the effects ...
8.4. Pediatric Use
Safety and effectiveness of TYMLOS have not been established in pediatric patients. TYMLOS is not recommended for use in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma ...
8.5. Geriatric Use
Of the total number of patients in the postmenopausal osteoporosis clinical studies of TYMLOS, 82% were age 65 years and over, and 19% were age 75 years and over. No overall differences in safety or effectiveness ...
8.6. Renal Impairment
No dosage adjustment is required for patients with mild, moderate, or severe renal impairment. A study of a single dose of TYMLOS 80 mcg given subcutaneously was conducted in subjects with normal renal ...
10. Overdosage
In a clinical study, accidental overdose was reported in a patient who received 400 mcg in one day (5 times the recommended clinical dose); dosing was temporarily interrupted. The patient experienced asthenia, ...
11. Description
TYMLOS injection for subcutaneous administration contains abaloparatide, a synthetic 34 amino acid peptide. Abaloparatide is an analog of human parathyroid hormone related peptide, PTHrP(1-34). It has ...
12.1. Mechanism of Action
Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. In rats and monkeys, abaloparatide ...
12.2. Pharmacodynamics
Effects on Markers of Bone Turnover A dose-finding study of abaloparatide administered once daily for 24 weeks demonstrated a dose-response relationship for BMD and bone formation markers. Daily administration ...
12.3. Pharmacokinetics
Following seven days of subcutaneous administration of abaloparatide 80 mcg, the mean (SD) abaloparatide exposure was 812 (118) pg/mL for C<sub>max</sub> and 1622 (641) pg·hr/mL for AUC<sub>0-24</sub> ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year carcinogenicity study, abaloparatide was administered once daily to male and female Fischer rats by subcutaneous injection at doses of 10, 25, and 50 mcg/kg. These doses resulted in systemic ...
13.2. Animal Toxicology and/or Pharmacology
In toxicity studies in rats and monkeys of up to 26-week and 39-week duration, respectively, findings included vasodilation, increases in serum calcium, decreases in serum phosphorus, and soft tissue mineralization ...
14. Clinical Studies
Efficacy Study in Women with Postmenopausal Osteoporosis The efficacy of TYMLOS for the treatment of postmenopausal osteoporosis was evaluated in Study 003 (NCT 01343004), an 18-month, randomized, multicenter, ...
16.1. How Supplied
TYMLOS injection is supplied as a pre-assembled single-patient-use disposable pen (NDC 70539-001-01) packaged in a cardboard carton (NDC 70539-001-02) with the Instructions for Use and Medication Guide. ...
16.2. Storage and Handling
Before first use, store TYMLOS in a refrigerator between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use). Risk of Osteosarcoma Advise patients that the active ingredient in TYMLOS, abaloparatide, caused ...