NATPARA (PARATHYROID HORMONE)- parathyroid hormone injection, powder, lyophilized, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

parathyroid hormone (UNII: N19A0T0E5J) (parathyroid hormone - UNII:N19A0T0E5J)

Dostopno od:

Takeda Pharmaceuticals America, Inc.

INN (mednarodno ime):

parathyroid hormone

Sestava:

parathyroid hormone 25 ug in 0.08 mL

Pot uporabe:

SUBCUTANEOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in 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. - NATPARA was not studied in patients with acute post-surgical hypoparathyroidism. NATPARA is contraindicated in patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, and urticaria) have occurred with NATPARA [see Warnings and Precautions (5.6), Adverse Reactions (6.3)] . Risk Summary Available data with NATPARA Injection use in pregnant women are insufficient to inform a drug associated risk of birth defects, miscarriage or adverse maternal or fetal out

Povzetek izdelek:

NATPARA (parathyroid hormone) for injection for subcutaneous use is supplied as a medication cartridge, which is comprised of a multiple-dose, dual-chamber glass cartridge containing a sterile lyophilized powder and a sterile diluent, within a plastic cartridge holder. The medication cartridge is available in 4 dosage strengths (25, 50, 75, and 100 mcg/dose). The 25 mcg/dose cartridge contains 0.4 mg parathyroid hormone; the 50 mcg/dose cartridge contains 0.8 mg parathyroid hormone; the 75 mcg/dose cartridge contains 1.21 mg parathyroid hormone; the 100 mcg/dose cartridge contains 1.61 mg parathyroid hormone. NATPARA is supplied in the following packages: The disposable NATPARA medication cartridge is designed for use with a reusable mixing device for product reconstitution and a reusable Q-Cliq pen injector for drug delivery. The Q-Cliq pen is designed to deliver a fixed volumetric dose of 71.4 µL. Using the Q-Cliq pen, each NATPARA medication cartridge delivers 14 doses; each dose contains 25, 50, 75, or 100 mcg of NATPARA depending on the product dosage strength. Designed for use with 31G × 8 mm BD Ultra-Fine™ Pen Needles. The mixing device, provided in a separate carton, is designed to enable reconstitution of the product before the first use of each cartridge. The mixing device can be used to reconstitute up to 6 NATPARA medication cartridges. The Q-Cliq pen, packaged in a separate carton, can be used for up to 2 years of daily treatment by replacing the reconstituted cartridge every two weeks (14 days). Instructions for use of the mixing device and the Q-Cliq pen are provided with the NATPARA medication cartridges. Prior to reconstitution, the dual-chamber NATPARA medication cartridge should be stored in the package provided at refrigerated temperature, 36 to 46°F (2 to 8°C). After reconstitution, the medication cartridge should be stored in the Q-Cliq pen under refrigeration at 36 to 46°F (2 to 8°C). The reconstituted product can be used for up to 14 days under these conditions. Store away from heat and light. Avoid exposure to elevated temperatures. Discard reconstituted NATPARA medication cartridges after 14 days. Do not freeze or shake. Do not use NATPARA if it has been frozen or shaken. The mixing device and empty Q-Cliq pen can be stored at room temperature. Safely discard needles.

Status dovoljenje:

Biologic Licensing Application

Navodilo za uporabo

NATPARA (PARATHYROID HORMONE)- PARATHYROID HORMONE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
NATPARA® (nat-PAH-rah)
(parathyroid hormone)
for injection
What is the most important information I should know about NATPARA?
•
possible bone cancer (osteosarcoma). During animal drug testing,
NATPARA caused some rats to
develop a bone cancer called osteosarcoma. It is not known if people
who take NATPARA will
have a higher chance of getting osteosarcoma. Tell your healthcare
provider right away if you
have pain in any areas of your body that does not go away, or any new
or unusual lumps or
swelling under your skin that is tender to touch. These are some of
the signs and symptoms of
osteosarcoma and your healthcare provider may need to do further
tests.
•
NATPARA is only available through the NATPARA Risk Evaluation and
Mitigation
Strategy (REMS) Program. The purpose of the NATPARA REMS program is to
inform
patients about the potential risk of osteosarcoma associated with the
use of NATPARA.
For more information about this REMS program, call 1-855-NATPARA
(1-855-628-7272)
or go to www.NATPARAREMS.com.
NATPARA may cause serious side effects, including:
•
high blood calcium (hypercalcemia). NATPARA can cause some people to
have a higher blood
calcium level than normal. Your healthcare provider should check your
blood calcium before you
start and during your treatment with NATPARA. Tell your healthcare
provider if you have nausea,
vomiting, constipation, low energy, or muscle weakness. These may be
signs that you have too
much calcium in your blood.
•
low blood calcium (hypocalcemia). People who stop using or miss a dose
of NATPARA may have
an increased risk of severe low blood calcium levels. Tell your
healthcare provider if you have
tingling of your lips, tongue, fingers and feet, twitching of face
muscles, cramping of feet and
hands, seizures, depression, or have problems thinking or remembering.
Tell your healthcare provider right away if you h

Lastnosti izdelka

NATPARA (PARATHYROID HORMONE)- PARATHYROID HORMONE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NATPARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NATPARA.
NATPARA (PARATHYROID HORMONE) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2015
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
IN MALE AND FEMALE RATS, PARATHYROID HORMONE CAUSED AN INCREASE IN THE
INCIDENCE
OF OSTEOSARCOMA (A MALIGNANT BONE TUMOR) THAT WAS DEPENDENT ON DOSE
AND
TREATMENT DURATION. A RISK TO HUMANS COULD NOT BE EXCLUDED (5.1, 13.1)
BECAUSE OF THE POTENTIAL RISK OF OSTEOSARCOMA, PRESCRIBE NATPARA ONLY
TO PATIENTS
WHO CANNOT BE WELL-CONTROLLED ON CALCIUM AND ACTIVE FORMS OF VITAMIN D
AND FOR
WHOM THE POTENTIAL BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL
RISK. (1, 5.1)
AVOID USE OF NATPARA IN PATIENTS WHO ARE AT INCREASED BASELINE RISK
FOR
OSTEOSARCOMA (INCLUDING THOSE 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 HISTORY OF PRIOR EXTERNAL BEAM OR IMPLANT RADIATION
THERAPY INVOLVING
THE SKELETON) (5.1)
NATPARA IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE
NATPARA REMS
PROGRAM (5.2)
INDICATIONS AND USAGE
NATPARA is a parathyroid hormone indicated as an adjunct to calcium
and vitamin D to control
hypocalcemia in patients with hypoparathyroidism. (1)
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. (5.1)
NATPARA was not studied in patients with hypoparathyroidism caused by
calcium-sensing receptor
mutations.
NATPARA was not studied in patients with acute post-surgical
hypoparathyro