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
Miacalcin Side Effects, and Drug Interactions - Calcitonin (salmon)
Miacalcin Side Effects, and Drug Interactions - Calcitonin (salmon)
SIDE EFFECTS
Gastrointestinal System
Injection: Nausea with or without vomiting
has been noted in about 10% of patients treated with calcitonin.
It is most evident when treatment is first initiated and tends to
decrease or disappear with continued administration.
Dermatologic/Hypersensitivity
Injection: Local inflammatory reactions at the site
of subcutaneous or intramuscular
injection have been
reported in about 10% of patients. Flushing of face
or hands occurred in about 2%-5% of patients. Skin rashes, nocturia,
pruritus of the ear
lobes, feverish sensation, pain in the eyes, poor appetite, abdominal
pain, edema of feet, and
salty taste have been reported in patients treated with Calcitonin (salmon).
Administration of Calcitonin (salmon) has been reported in a few cases
to cause serious allergic-type
reactions (e.g., bronchospasm, swelling
of the tongue or throat, and anaphylactic shock), and in one case,
death attributed to anaphylaxis
(see WARNINGS).
Nasal Spray: The incidence
of adverse reactions reported in studies involving postmenopausal
osteoporotic patients chronically exposed to Calcitonin (salmon) nasal
spray (N=341) and to placebo
nasal spray (N=131) and
reported in greater than 3% of Calcitonin (salmon) nasal
spray treated patients are presented below in the following table
(TABLE 1). Most adverse reactions were mild to moderate in severity.
Nasal adverse events were most common with 70% mild, 25% moderate,
and 5% severe in nature (placebo rates were 71% mild, 27% moderate,
and 2% severe).
| TABLE 1 Adverse Reactions Occurring
in at Least 3% of Postmenopausal Patients Treated Chronically |
| Miacalcin (Calcitonin (salmon)) |
| |
Nasal Spray |
Placebo |
| |
N=341 |
N=131 |
| Adverse Reaction |
% of Patients |
% of Patients |
| Rhinitis |
12.0 |
6.9 |
| Symptom of Nose† |
10.6 |
16.0 |
| Back Pain |
5.0 |
2.3 |
| Arthralgia |
3.8 |
5.3 |
| Epistaxis |
3.5 |
4.6 |
| Headache |
3.2 |
4.6 |
| † Symptom of nose
includes: nasal
crusts, dryness, redness or erythema, nasal
sores, irritation, itching, thick feeling, soreness, pallor,
infection, stenosis, runny/blocked, small wound, bleeding
wound, tenderness, uncomfortable feeling
and sore across bridge
of nose. |
In addition, the following adverse events were reported in fewer
than 3% of patients during chronic
therapy with Calcitonin (salmon) nasal
spray. Adverse events reported in 1%-3% of patients are identified
with an asterisk (*). The remainder occurred in less than 1% of
patients. Other than flushing, nausea, possible allergic
reactions, and possible local
irritative effects
in the respiratory tract, a relationship to Calcitonin (salmon) nasal
spray has not been established.
Body as a Whole (General Disorders): Influenza-like
symptoms*, fatigue*, periorbital
edema, fever.
Integumentary: Erythematous rash*, skin
ulceration, eczema, alopecia, pruritus, increased sweating.
Musculoskeletal/Collagen: Arthrosis*, myalgia*, arthritis,
polymyalgia rheumatica, stiffness.
Respiratory/Special Senses: Sinusitis*, upper respiratory
tract infection*, bronchospasm*, pharyngitis, bronchitis, pneumonia,
coughing, dyspnea, taste
perversion, parosmia.
Cardiovascular: Hypertension*, angina
pectoris*, tachycardia, palpitation, bundle
branch block, myocardial
infarction.
Gastrointestinal: Dyspepsia*, constipation*, abdominal
pain*, nausea*, diarrhea*, vomiting, flatulence, increased appetite,
gastritis, dry mouth.
Liver/Metabolic: Cholelithiasis, hepatitis, thirst,
weight increase.
Endocrine: Goiter, hyperthyroidism.
Urinary System: Cystitis*, pyelonephritis, hematuria,
renal calculus.
Central and Peripheral Nervous System: Dizziness*,
paresthesia*, vertigo, migraine, neuralgia, agitation.
Hearing/Vestibular: Tinnitus, hearing
loss, earache.
Vision: Abnormal lacrimation*, conjunctivitis*, blurred
vision, vitreous floater.
Vascular: Flushing, cerebrovascular
accident, thrombophlebitis.
Hematologic/Resistance Mechanisms: Lymphadenopathy*,
infection*, anemia.
Psychiatric: Depression*, insomnia, anxiety, anorexia.
Common adverse reactions associated with the use of injectable
Calcitonin (salmon) occurred less frequently in patients treated with
Calcitonin (salmon) nasal spray than in those patients treated with
injectable calcitonin.
Nausea, with or without vomiting, which occurred in 1.8% of patients
treated with the nasal
spray (and 1.5% of those receiving placebo
nasal spray) occurs in
about 10% of patients who take
injectable Calcitonin (salmon).
Flushing, which occurred in less than 1% of patients treated with
the Nasal Spray, occurs in 2%-5% of patients treated with injectable
Calcitonin (salmon). Although the administered dosages of injectable
and nasal spray Calcitonin (salmon)
are comparable (50-100 units daily of injectable
versus 200 units daily of nasal
spray), the nasal dosage
form has a mean
bioavailability of about 3% (range 0.3%- 30.6%) and therefore provides
less drug to the systemic
circulation, possibly accounting for the decrease in frequency of
adverse reactions.
The collective foreign marketing experience
with Miacalcin (Calcitonin (salmon)) Nasal Spray does not show evidence
of any notable difference in the incidence profile of reported adverse
reactions when compared with that seen in the clinical trials.
DRUG INTERACTIONS
Nasal Spray: Formal studies designed to evaluate
drug interactions with Calcitonin (salmon) have not been done. No
drug interaction studies
have been performed with Calcitonin (salmon) nasal
spray ingredients.
Currently, no drug interactions
with Calcitonin (salmon) have been observed. The effects of prior use
of diphosphonates in postmenopausal
osteoporosis patients have not been assessed; however, in patients with
Paget's Disease prior diphosphonate use appears to reduce
the anti-resorptive response to Calcitonin (salmon) nasal
spray.
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