Tymlos (abaloparatide)

No dosing information is available for this tab.

Abaloparatide is administered by subcutaneous injection once daily. Subcutaneous injections should be administered into the periumbilical region of the abdomen (taking care to avoid the 2-inch area around the navel) at the same time every day. The injection site should be rotated with each administration. The drug should not be given by IV or IM administration.

Abaloparatide is commercially available as a clear and colorless solution in a single-patient-use prefilled injection pen that delivers 80 mcg of the drug per actuation. Prior to injection, abaloparatide should be visually inspected for particulate matter and discoloration. The solution should not be used if it contains solid particles or appears cloudy or colored. Each injection pen may be used for up to 30 days after the first injection and should then be disposed of properly, even if the injection pen contains unused solution.

Patients and caregivers should receive appropriate training and instruction on the proper use and disposal of the abaloparatide injection pen.

Abaloparatide should be administered initially in a setting in which the patient can assume a supine or sitting position if symptoms of orthostatic hypotension occur.

No dosing information is available for this tab.

No formal drug interaction studies with abaloparatide have been performed to date. Abaloparatide does not inhibit or induce cytochrome P-450 (CYP) isoenzymes at therapeutic concentrations based on in vitro studies. Abaloparatide is not a substrate of organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, multidrug and toxin extrusion (MATE)1, or MATE2K.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to abaloparatide or any component of the formulation.

• Bone metastases of solid tumors
• Prior radiation therapy involving bone

• Hypercalcemia due to primary hyperparathyroidism

• Urolithiasis

Common adverse effects reported with abaloparatide in postmenopausal women at an incidence >=2% include hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.

Common adverse effects reported with abaloparatide in men with osteoporosis at an incidence >=2% include injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, confusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain.

Less Frequent

• Urolithiasis

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Dyspnea
• Hypersensitivity drug reaction
• Osteosarcoma of bone

More Frequent

• Dizziness
• Fatigue
• Headache disorder
• Hypercalcinuria
• Hyperuricemia
• Injection site erythema
• Injection site sequelae
• Nausea
• Palpitations
• Upper abdominal pain
• Vertigo

Less Frequent

• Injection site pain
• Orthostatic hypotension
• Tachycardia

Rare or Very Rare

• Abdominal distension
• Acute abdominal pain
• Arthralgia
• Back pain
• Bone pain
• Constipation
• Diarrhea
• General weakness
• Hypercalcemia
• Hypertension
• Insomnia
• Lethargy
• Malaise
• Muscle spasm
• Pain
• Pain in extremities
• Pruritus of skin
• Skin rash
• Urticaria
• Vomiting

No enhanced messaging available.

Safety and efficacy of abaloparatide have not been established in pediatric patients. Use of abaloparatide is not recommended in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma.

Abaloparatide should not be used in females of reproductive potential. There are no data regarding use of abaloparatide in pregnant women to inform any drug-associated risks. Animal reproduction studies with abaloparatide have not been performed.

It is not known whether abaloparatide is distributed into milk in humans or whether the drug has any effects on milk production or the breast-fed infant.

Of the total number of patients in the postmenopausal osteoporosis clinical studies of abaloparatide, 82% of patients were >=65 years of age, and 19% were >=75 years of age. In the study in men with osteoporosis, 74% of patients were >=65 years of age and 23% were >=75 years of age. No overall differences in safety or efficacy were observed between geriatric patients and younger adults; however, greater sensitivity of some older patients cannot be ruled out.