Natpar 25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection parathyroid
hormone ( parathyroid hormone )
What Natpar is and what it is used for
What is Natpar?
Natpar is a hormone replacement for adults with impaired parathyroid function, a condition called “hypoparathyroidism”.
Hypoparathyroidism is a disease caused by low levels of parathyroid hormone, which is produced by the parathyroid glands in the throat. This hormone controls the amount of calcium and phosphate in the blood and urine.
If your parathyroid hormone levels are too low, you may have low calcium levels in your blood. Low calcium levels can lead to symptoms in many parts of the body, including the skeleton, heart, skin, muscles, kidneys, brain, and nerves. A list of low calcium symptoms can be found in section 4.
Natpar is a synthetic form of parathyroid hormone that helps keep calcium and phosphate levels in the blood and urine at a normal level.
What you need to know before using Natpar
Do not use Natpar
- if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6).
- if you are receiving or have previously received radiation therapy to the skeleton
- if you have skeletal cancer or other cancers that have spread to the skeleton
- if you are at increased risk of developing a skeletal cancer called osteosarcoma (eg if you have Paget’s disease or other skeletal diseases)
- if a blood test shows that you have unexplained increases in skeletal specific alkaline phosphatase
- if you have pseudohypoparathyroidism, a rare condition in which the body does not respond satisfactorily to the parathyroid hormone produced by the body.
Warnings and cautions
Talk to a doctor, pharmacist, or nurse before using Natpar.
If you are being treated with Natpar, you may experience side effects associated with low or high levels of calcium in your blood (see section 4 for these side effects ).
These side effects are more likely to occur:
- when you start with Natpar
- if you change Natpar‑ dose one
- if you forget one of your daily injections
- if you stop taking Natpar for a short time or completely.
You may be given additional medicines to treat or prevent these side effects, or you may be asked to stop taking some of the medicines you are taking. These drugs include calcium or vitamin D.
If you have severe symptoms, your doctor may give you additional medication.
Your doctor will check your calcium levels. You may need to change the dose of Natpar‑ or stop giving the injections for a short time.
Samples and controls
Your doctor will check how you respond to the treatment:
- during the first 7 days after starting treatment and
- if your dose changes.
This will be done using samples to measure the level of calcium in the blood or urine. Your doctor may ask you to change the amount of calcium or vitamin D you are taking (in any form, including calcium-rich foods).
Talk to your doctor or pharmacist before using Natpar if you suffer from kidney stones.
Children and young people
Night couples should not be used for children or adolescents under 18 years of age.
Other drugs and Natpar
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
- digoxin , also called digitalis , a heart medicine
- drugs used to treat osteoporosis called bisphosphonates, such as alendronic acid
- Drugs that can affect the calcium levels in the blood, such as lithium or certain drugs that are used to increase the amount of urine ( diuretics ).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is a limited amount of data from the use of Natpar in pregnant women. Natpar has been shown to pass into breast milk in rats, but it is unknown whether Natpar passes into human breast milk.
Your doctor will decide if you should start treatment with Natpar. Your doctor will also decide if you should continue to take this medicine if you become pregnant or start breastfeeding when you take it.
It is not known if Natpar has any effect on fertility.
Driving and using machines
Night couples do not affect the ability to drive and use machines. However, hypoparathyroidism itself can affect your ability to concentrate. If your ability to concentrate is impaired, do not drive or use machines until your ability to concentrate has improved.
Night pairs contain sodium
This medicine contains 1 mmol (or 23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Natpar
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor or nurse will show you how to use the Natpar pen.
Natpar is given as a subcutaneous (under the skin) injection every day, with a pen to help you inject the medicine.
The “reusable Natpar pen” is called the “Natpar pen” or “pen” in this information.
Dose
The recommended starting dose of Natpar is 50 micrograms per day.
- However, your doctor may start by giving you 25 micrograms a day based on a blood test result.
- After 2 to 4 weeks, your doctor may adjust dose one.
Dose one of Natpar varies from person to person. You may need between 25 and 100 micrograms of Natpar per day.
Your doctor may ask you to take other medicines such as calcium supplements or vitamin D while you are taking Natpar. Your doctor will tell you how much to take each day.
How to use the pen
Read “Section 7. Instructions for Use” in this information before using the pen.
Do not use the pen if the solution is cloudy or colored or contains visible particles.
The medicine must be mixed before using the pen for the first time.
After mixing the medicine, the Natpar pen is ready for use and the medicine can be injected under the skin of the thigh. Inject into the other thigh the next day and continue to switch between the two thighs.
It is strongly recommended that the name and lot of the product on the kit (lot) be noted each time you receive a dose of Natpar to maintain a list of the kits that have been used.
How long to use Natpar
Continue to use Natpar for as long as your doctor prescribes it.
If you have used too much Natpar
If you accidentally inject more than one dose of Natpar a day, contact your doctor or pharmacist immediately.
If you forget to use Natpar
If you forget to use Natpar (or can not inject it at the usual time), inject as soon as you can but do not inject more than one dose on the same day.
Take the next dose of Natpar at the usual time the next day. You may need to take more calcium supplements if you have signs of low levels of calcium in your blood; see section 4 for symptoms.
Do not inject a double dose to make up for a forgotten dose.
If you stop using Natpar
Discuss with your doctor if you want to stop using Natpar.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
The following potentially serious side effects may occur when using Natpar:
- Very common: high levels of calcium in the blood, which may occur more often when you start treatment with Natpar.
- Very common: low levels of calcium in the blood; this can occur more often if you suddenly stop using Natpar.
Symptoms associated with high or low calcium levels are listed below. If you experience any of these side effects, contact your doctor immediately.
Other side effects may include:
Very common (may affect more than 1 user in 10):
- headache *, †
- tingling and numbness in the skin †
- diarrhea *, †
- nausea and vomiting *
- joint pain *
- muscle spasms †
Common (may affect up to 1 in 10 people):
- feeling of nervousness or anxiety †
- sleep problems (feeling sleepy during the day or trouble sleeping at night) *
- fast or irregular heartbeat *, †
- high blood pressure *
- cough †
- stomach pain *
- muscle twitching or cramps †
- muscle pain †
- neck pain †
- pain in arms and legs
- increased level of calcium in the urine *
- need to urinate often †
- fatigue and lack of energy *
- chest pain
- redness and pain at the injection site
- thirst *
- antibodies (produced by your immune system) against Natpar
- In blood tests, the doctor may see decreased levels of vitamin D and magnesium †
Has been reported (occurs in an unknown number of users):
- allergic reactions (hypersensitivity), may cause symptoms such as: swelling of the face, lips, mouth or tongue; shortness of breath; itching; rash; hives
- seizures due to low levels of calcium in the blood †
* These side effects may be related to high levels of calcium in the blood.
† These side effects may be related to low levels of calcium in the blood.
How to store Natpar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge and the carton after EXP. The expiration date is the last day of the specified month.
Before mixing
- Store in a refrigerator (2 ° C-8 ° C).
- Do not freeze.
- Store cartridge one in the cartridge holder in the outer carton. Sensitive to light.
After mixing
- Store in a refrigerator (2 ° C-8 ° C).
- Do not freeze.
- Keep the pen containing a mixed cartridge tightly closed. Sensitive to light.
- Do not use this medicine for more than 14 days after mixing it.
- Do not use this medicine if it has not been stored properly.
- Before attaching a new needle to the Natpar pen, check that the solution is clear and colorless. It is normal for small bubbles to appear. Do not use this medicine if the solution is cloudy, colored or contains visible particles.
Medicines should not be disposed of via household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is parathyroid hormone (rDNA).
The medicine is available in 4 different strengths in cartridges (one cartridge contains 14 doses):
Natpar 25 micrograms
One dose contains 25 micrograms of parathyroid hormone in 71.4 microliters of solution after reconstitution.
Natpar 50 micrograms
One dose contains 50 micrograms of parathyroid hormone in 71.4 microliters of solution after reconstitution.
Natpar 75 micrograms
One dose contains 75 micrograms of parathyroid hormone in 71.4 microliters of solution after reconstitution.
Natpar 100 micrograms
One dose contains 100 micrograms of parathyroid hormone in 71.4 microliters of solution after reconstitution.
The other ingredients in cartridge one (for all strengths) are:
In the powder:
- sodium chloride
- mannitol
- citric acid monohydrate
- sodium hydroxide (for pH adjustment)
In the liquid:
- metacresol
- water for injection solution ar
What the medicine looks like and contents of the pack
A cartridge Natpar contains medicines in the form of a powder together with a liquid to make a solution for injection. Cylinder cartridge one is made of glass with a rubber seal at the top. The cartridge is enclosed in a plastic container.
Natpar is available in packs of 2 cartridges in a holder.
The color of the carton/cartridge shows the strength of Natpar:
Natpar 25 micrograms / dose
Purple cartridge
Natpar 50 micrograms / dose
Red cartridge
Natpar 75 micrograms / dose
Gray cartridge
Natpar 100 micrograms / dose
Blue cartridge
Marketing Authorization Holder and Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
Tel: +800 66838470
Email: medinfoEMEA@takeda.com