Abaloparatide
Abaloparatide is indicated for treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Source:
EMA
Active Ingredients:
Indications
Representation
Inaccurate sex representation in patient population
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
33.6%
66.4%
Clinical study participation by sex
0%
100%
Representation Gap
Inaccurate sex representation
-33.6%
+33.6%
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; efficacy data were generated in postmenopausal women only.
Sex-specific posology
No sex-specific data
No sex- or gender-based dose adjustment is described.
Sex-specific differences in possible side effects
No sex-specific data
No sex-based adverse-event comparison was reported; safety data were reported in women with postmenopausal osteoporosis only.
Pregnancy / lactation
N / A
Abaloparatide is not indicated in women of childbearing potential and must not be used in women who are or may be pregnant or who are breast-feeding. It is contraindicated during pregnancy and during breast-feeding. It is unknown whether abaloparatide is excreted in human milk, and a risk to newborns or infants cannot be excluded.
Sex-specific non-clinical findings
In rats, abaloparatide showed no effects on male fertility.
No human fertility data are available. No embryofoetal or pre/postnatal development studies were conducted in female animals because the intended population is postmenopausal women.
Disease prevalence by sex
Men
33.6%
Women
66.4%
Clinical study participation by sex
Men
0%
Women
100%
Representation Gap
Inaccurate sex representation
Men
-33.6%
Women
+33.6%
Sex-specific efficacy/accuracy
No sex-specific data
No sex-based efficacy comparison was reported; efficacy data were generated in postmenopausal women only.
Sex-specific posology
No sex-specific data
No sex- or gender-based dose adjustment is described.
Sex-specific differences in possible side effects
No sex-specific data
No sex-based adverse-event comparison was reported; safety data were reported in women with postmenopausal osteoporosis only.
Pregnancy / lactation
Men
N / A
Women
Abaloparatide is not indicated in women of childbearing potential and must not be used in women who are or may be pregnant or who are breast-feeding. It is contraindicated during pregnancy and during breast-feeding. It is unknown whether abaloparatide is excreted in human milk, and a risk to newborns or infants cannot be excluded.
Sex-specific non-clinical findings
Men
In rats, abaloparatide showed no effects on male fertility.
Women
No human fertility data are available. No embryofoetal or pre/postnatal development studies were conducted in female animals because the intended population is postmenopausal women.
General information
General Efficacy
Primary endpoints: Incidence of new vertebral fractures versus placebo at 18 months in the ACTIVE study. Secondary endpoints: Supportive outcomes included incidence of non-vertebral fractures, BMD change at the lumbar spine, total hip, femoral neck and ultra-distal radius at 6, 12 and 18 months, bone turnover markers s-PINP and s-CTX, and longer-term fracture and BMD outcomes in ACTIVExtend.
General Posology
80 micrograms by subcutaneous injection once daily in the lower abdomen, rotating injection sites daily and administering at approximately the same time each day. Maximum total treatment duration is 18 months. Supplemental calcium and vitamin D should be given if dietary intake is inadequate.
Further Dose Adjustments
Use is contraindicated in severe renal impairment and in patients with pre-existing hypercalcaemia, unexplained elevations of serum alkaline phosphatase, known osteosarcoma risk including prior skeletal radiation, or skeletal malignancies or bone metastases.
Possible Side Effects
Very common adverse reactions were dizziness and hypercalciuria. The most commonly reported adverse reactions in ACTIVE also included back pain, nausea, headache, arthralgia, hypertension, injection site reaction and palpitations. Serious reported reactions included hypersensitivity and anaphylactic reaction.
Contraindications
Hypersensitivity to the active substance or excipients; pregnancy and breast-feeding; women of childbearing potential; pre-existing hypercalcaemia; severe renal impairment; unexplained elevations of serum alkaline phosphatase; known osteosarcoma risk such as prior external beam or implant radiation therapy involving the skeleton; and skeletal malignancies or bone metastases.
Clinical Trial Type and Population
The safety and efficacy were evaluated primarily in the randomized ACTIVE study in postmenopausal women with osteoporosis, with supportive follow-up in the open-label ACTIVExtend extension. ACTIVE: n=2,070, mean age 69 years, women 100%. ACTIVExtend: n=963, mean age not reported, women percentage not separately reported.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Date of first authorisation:
12 December 2022
Source URL:
Prevalence Source: