A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Forteo Side Effects, and Drug Interactions - Teriparatide (rDNA origin) Inj
Forteo Side Effects, and Drug Interactions - Teriparatide (rDNA origin) Inj
SIDE EFFECTS
The safety of teriparatide has been evaluated in 24 clinical trials that enrolled over 2800 women and men. Four long-term Phase 3 clinical trials included 1 large placebo-controlled, double-blind, multinational trial with 1637 postmenopausal women; 1 placebo-controlled, double-blind, multinational trial with 437 men; and 2 active-controlled trials including 393 postmenopausal women. Teriparatide doses ranged from 5 to 100 mcg/day in short-term trials and 20 to 40 mcg/day in the other trials. A total of 1943 of the patients studied received teriparatide, including 815 patients at 20 mcg/day and 1107 patients at 40 mcg/day. In the clinical trials, a total of 1432 patients were treated with teriparatide for 3 months to 2 years, of whom 1137 were treated for greater than 1 year (500 at 20 mcg/day and 637 at 40 mcg/day). The maximum duration of treatment was 2 years. Adverse events associated with FORTEO usually were mild and generally did not require discontinuation of therapy.
In the two Phase 3 placebo-controlled clinical trials in men and postmenopausal women, early discontinuation due to adverse events occurred in 5.6% of patients assigned to placebo and 7.1% of patients assigned to FORTEO. Reported adverse events that appeared to be increased by FORTEO treatment were dizziness and leg cramps.
Table 5 lists adverse events that occurred in the two Phase 3 placebo-controlled clinical trials in men and postmenopausal women at a frequency ³2.0% in the FORTEO groups and in more FORTEO-treated patients than in placebo-treated patients, without attribution of causality.
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Table 5. Percentage of Patients with Adverse Events Reported by at Least 2% of FORTEO-Treated Patients and in More FORTEO-Treated Patients than Placebo-Treated Patients from the Two Principal Osteoporosis Trials in Women and Men Adverse Events are Shown Without Attribution of Causality
|
|
FORTEO N=691
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Placebo N=691
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|
Event Classification
|
(%)
|
(%)
|
|
Body as a Whole
|
Pain
|
21.3
|
20.5
|
Headache
|
7.5
|
7.4
|
Asthenia
|
8.7
|
6.8
|
Neck pain
|
3.0
|
2.7
|
|
Cardiovascular
|
Hypertension
|
7.1
|
6.8
|
Angina pectoris
|
2.5
|
1.6
|
Syncope
|
2.6
|
1.4
|
|
Digestive System
|
Nausea
|
8.5
|
6.7
|
Constipation
|
5.4
|
4.5
|
Diarrhea
|
5.1
|
4.6
|
Dyspepsia
|
5.2
|
4.1
|
Vomiting
|
3.0
|
2.3
|
Gastrointestinal disorder
|
2.3
|
2.0
|
Tooth disorder
|
2.0
|
1.3
|
|
Musculoskeletal
|
Arthralgia
|
10.1
|
8.4
|
Leg cramps
|
2.6
|
1.3
|
|
Nervous System
|
Dizziness
|
8.0
|
5.4
|
Depression
|
4.1
|
2.7
|
Insomnia
|
4.3
|
3.6
|
Vertigo
|
3.8
|
2.7
|
|
Respiratory System
|
Rhinitis
|
9.6
|
8.8
|
Cough increased
|
6.4
|
5.5
|
Pharyngitis
|
5.5
|
4.8
|
Dyspnea
|
3.6
|
2.6
|
Pneumonia
|
3.9
|
3.3
|
|
Skin and Appendages
|
Rash
|
4.9
|
4.5
|
Sweating
|
2.2
|
1.7
|
Serum calcium — FORTEO transiently increases serum calcium, with the maximal effect observed at approximately 4 to 6 hours post-dose. Serum calcium measured at least 16 hours post-dose was not different from pretreatment levels. In clinical trials, the frequency of at least 1 episode of transient hypercalcemia in the 4 to 6 hours after FORTEO administration was increased from 1.5% of women and none of the men treated with placebo to 11.1% of women and 6.0% of men treated with FORTEO. The number of patients treated with FORTEO whose transient hypercalcemia was verified on consecutive measurements was 3.0% of women and 1.3% of men.
Immunogenicity — In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving FORTEO. Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy. There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response.
Postmarketing Reports
Since market introduction, adverse events reported have included:
• Possible allergic events soon after injection: acute dyspnea, oro/facial edema, generalized urticaria, chest pain. (less than 1 in 1000 patients treated).
• Hypercalcemia greater than 2.76 mmol/L (11 mg/dL) (less than 1 in 100 patients treated); hypercalcemia greater than 3.25 mmol/L (13 mg/dL) (less than 1 in 1000 patients treated).
• Injection site and injection technique events including pain, swelling, erythema, localized bruising, pruritus and minor bleeding at the injection site (less than 1 in 30 patients treated). These usually have been mild and transient.
DRUG INTERACTIONS
Refer to the Drug Interactions under CLINICAL PHARMACOLOGY
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