NATPARA 50 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RECOMBINANT HUMAN PARATHYROID HORMONE

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

H05AA03

Pharmaceutical form:

LYOPHYLIZED POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

RECOMBINANT HUMAN PARATHYROID HORMONE 50 MCG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

SHIRE NPS PHARMACEUTICALS INC., USA

Therapeutic area:

PARATHYROID HORMONE

Therapeutic indications:

NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in adult patients with hypoparathyroidism

Authorization date:

2021-04-30

Patient Information leaflet

NATPARA
®
(PARATHYROID HORMONE) FOR INJECTION
RISK MANAGEMENT PROGRAM
HEALTH CARE PROFESSIONAL
SAFETY GUIDE
This document was last approved in April 2020 by The Israeli Ministry
of Health (MOH)
NATPARA HEALTH CARE PROFESSIONAL SAFETY GUIDE
INDICATION:
NATPARA is a parathyroid hormone indicated as an adjunct to calcium
and
vitamin D to control hypocalcemia in patients with hypoparathyroidism.
NATPARA is not a parathyroid hormone replacement.
LIMITATIONS OF USE:
• Because of the potential risk of osteosarcoma, NATPARA is
recommended
only for patients who cannot be well-controlled on calcium and active
forms
of vitamin D alone.
• NATPARA was not studied in patients with hypoparathyroidism caused
by
calcium sensing receptor mutations
• NATPARA was not studied in patients with acute post-surgical
hypoparathyroidism
POTENTIAL RISK OF OSTEOSARCOMA
•
NATPARA causes an increase in the incidence of osteosarcoma in rats
•The increase in rats is dependent on NATPARA dose and treatment
duration.
•A risk to humans could not be excluded.
APPROPRIATE PATIENT SELECTION
•Due to the potential risk of osteosarcoma, NATPARA is only
recommended
for patients who cannot be well-controlled on calcium and active forms
of
vitamin D alone and for whom the potential benefits are considered to
outweigh this potential risk.
•Avoid use of NATPARA in patients who are at increased risk for
osteosarcoma, such as:
–Patients with Paget’s disease of bone or unexplained elevations
of
alkaline phosphatase
–Pediatric and young adult patients with open epiphyses
–Patients with hereditary disorders predisposed to osteosarcoma
–Patients with a prior history of external beam or implant radiation
therapy involving the skeleton
PATIENT COUNSELING ON BENEFITS AND RISKS OF NATPARA
•Counsel the patient on the benefits and risks of NATPARA and the
potential
risk of osteosarcoma .
• Refer the patient to the "Patient Brochure"
•Guide your patient to report you right away if any of the following
signs or
symptoms appeared that could

Summary of Product characteristics

Page 1 of 19
NATPARA
® 25 MCG
NATPARA
® 50 MCG
NATPARA
® 75 MCG
NATPARA
® 100 MCG
_ _
_PARATHYROID HORMONE _
_LYOPHILIZED POWDER AND SOLVENT FOR SOLUTION FOR SUBCUTANEOUS
INJECTION _
_ _
WARNING: POTENTIAL RISK OF OSTEOSARCOMA

IN MALE AND FEMALE RATS, PARATHYROID HORMONE CAUSED AN INCREASE IN THE
INCIDENCE OF
OSTEOSARCOMA (A MALIGNANT BONE TUMOR). THE OCCURRENCE OF OSTEOSARCOMA
WAS DEPENDENT ON
PARATHYROID HORMONE DOSE AND TREATMENT DURATION. THIS EFFECT WAS
OBSERVED AT PARATHYROID
HORMONE EXPOSURE LEVELS RANGING FROM 3 TO 71 TIMES THE EXPOSURE LEVELS
IN HUMANS RECEIVING
A 100 MCG DOSE OF NATPARA. THESE DATA COULD NOT EXCLUDE A RISK TO
HUMANS _[SEE WARNINGS _
_AND PRECAUTIONS (5.1), NONCLINICAL TOXICOLOGY (12.1)]._

BECAUSE OF A POTENTIAL RISK OF OSTEOSARCOMA, USE NATPARA ONLY IN
PATIENTS WHO CANNOT BE
WELL-CONTROLLED ON CALCIUM AND ACTIVE FORMS OF VITAMIN D ALONE AND FOR
WHOM THE POTENTIAL
BENEFITS ARE CONSIDERED TO OUTWEIGH THIS POTENTIAL RISK _[SEE
INDICATIONS AND USAGE (1) AND _
_WARNINGS AND PRECAUTIONS (5.1)]._

AVOID USE OF NATPARA IN PATIENTS WHO ARE AT INCREASED BASELINE RISK
FOR OSTEOSARCOMA SUCH
AS PATIENTS WITH PAGET’S DISEASE OF BONE OR UNEXPLAINED ELEVATIONS
OF ALKALINE PHOSPHATASE,
PEDIATRIC AND YOUNG ADULT PATIENTS WITH OPEN EPIPHYSES, PATIENTS WITH
HEREDITARY DISORDERS
PREDISPOSING TO OSTEOSARCOMA OR PATIENTS WITH A PRIOR HISTORY OF
EXTERNAL BEAM OR IMPLANT
RADIATION THERAPY INVOLVING THE SKELETON _[SEE WARNINGS AND
PRECAUTIONS (5.1)]._
1
INDICATIONS AND USAGE
NATPARA is a parathyroid hormone indicated as an adjunct to calcium
and vitamin D to control
hypocalcemia in adult patients with hypoparathyroidism.
Limitations of Use:

Because of the potential risk of osteosarcoma, NATPARA is recommended
only for patients who
cannot be well-controlled on calcium supplements and active forms of
vitamin D alone. _[see Warnings _
_and Precautions (5.1)]_

NATPARA was not studied in patients with hypoparathyroidism caused by
calcium-sensing receptor
mutations.
Page 2 of 19

NATPARA wa