2.5 mg, 5 mg, 10 mg solution for injection ,
ethyl calcite solution
What Parsabiv is and what it is used for
Parsabiv contains the active substance etelkalcetid which lowers the levels of parathyroid hormone ( parathyroid hormone ), so-called PTH.
Parsabiv is used to treat secondary hyperparathyroidism in patients with severe kidney disease who need hemodialysis treatment to cleanse the blood of waste products.
In secondary hyperparathyroidism, the parathyroid glands (four small glands on the neck) produce too much PTH. “Secondary” means that hyperparathyroidism is caused by another condition, e.g. kidney disease. Secondary hyperparathyroidism can cause loss of calcium from the skeleton, which can lead to skeletal pain and bone fractures as well as problems with blood vessels in the heart and the rest of the body. By controlling PTH levels, Parsabiv helps control the levels of calcium and phosphate in your body.
What you need to know before using Parsabiv
Do not use Parsabiv
Do not use Parsabiv
- if you are allergic to ethyl calcite or any of the other ingredients of this medicine (listed in section 6).
- if you have very low calcium levels in your blood. Your doctor will check your blood calcium levels.
Warnings and cautions
Before you take Parsabiv, tell your doctor if you have or have had:
- heart problems, such as heart failure or arrhythmia (abnormal heart rhythm)
- seizures.
Parsabiv lowers calcium levels. Tell your doctor if you experience spasms, twitches or cramps in your muscles, numbness or tingling in your fingers, toes, or around your mouth, or seizures, confusion, or loss of consciousness while you are being treated with Parsabiv. Further information can be found in section 4.
Low calcium levels can cause abnormal heart rhythms. Tell your doctor if you have an unusually fast or throbbing heartbeat, if you have a heart rhythm problem or heart failure or if you are taking medicines that can cause a heart rhythm problem, while you are receiving Parsabiv. Further information can be found in section 4.
Very low levels of PTH over long periods can lead to a type of abnormal structure of the skeleton called adynamic bone disease. This disease can only be diagnosed with a biopsy (method of sampling living tissue from the body). Your PTH levels will be monitored during treatment with Parsabiv and your dose of Parsabiv may be reduced if your PTH levels become very low.
Children and young people
It is not known if Parsabiv is safe and effective in children under 18 years of age, as it has not been studied in these patients.
Other medicines and Parsabiv
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, or other medicines that lower serum calcium (eg cinacalcet and denosumab).
You should not be given Parsabiv with cina calcium. Tell your doctor if you are taking Cina Calcium or have recently taken Cina Calcium.
Pregnancy
Parsabiv has not been tested in pregnant women. It is not known if Parsabiv can harm your unborn baby. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby while you are taking Parsabiv. As a precautionary measure, the use of Parsabiv during pregnancy should be avoided.
Breast-feeding
It is unknown if Parsabiv passes into breast milk. Tell your doctor if you are breastfeeding or planning to do so. Your doctor will help you decide if you should stop breastfeeding or stop taking Parsabiv. This takes into account the baby’s benefit from breastfeeding and the mother’s benefit from Parsabiv.
Driving and using machines
Parsabiv has no or negligible effect on the ability to drive and use machines. However, some symptoms of low calcium levels (such as seizures) may affect the ability to drive or use machines.
Parsabiv contains sodium
Important information about some of the ingredients of Parsabiv
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Parsabiv
The recommended starting dose of Parsabiv is 5 mg. It will be given by a doctor or nurse at the end of your hemodialysis treatment via the tubing (blood tubing) connected to the hemodialysis machine. Parsabiv will be given 3 times a week. Dose one can be increased up to 15 mg or lowered to 2.5 mg, depending on how you respond to treatment.
You may need to take calcium and vitamin D supplements during treatment with Parsabiv. Your doctor will discuss this with you.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood calcium levels (hypocalcemia) have been reported frequently (may affect up to 1 in 10 people). If you feel numbness or tingling around the mouth or in the arms and/or legs, muscle aches or cramps, and seizures, tell your doctor immediately. This may be a sign that your calcium levels are too low.
Very common: may affect more than 1 user in 10
- Nausea
- Vomiting
- Diarrhea
- Muscle spasms
- Low calcium levels in the blood without symptoms
Common: may affect up to 1 in 10 users
- High potassium levels in the blood
- Low phosphate levels in the blood
- Headache
- Numbness or stinging sensation
- Exacerbated heart failure
- Disorders of the heart’s electrical activity, which is seen as a deviation ( QT prolongation) on an ECG
- Low blood pressure
- Muscle aches
Uncommon: may affect up to 1 in 100 people
- Seizures. Further information can be found in section 2
Has been reported: occurs in an unknown number of users
- Allergic reactions (including anaphylactic reactions).
How to store Parsabiv
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 carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Keep the vial in the outer carton. Sensitive to light.
Once removed from the refrigerator:
- Parsabiv is stable for a maximum of a total of 7 days if stored in the original box. There are no special temperature requirements for storage.
- Withdrawn from the original box, Parsabiv is durable for a maximum of 4 hours if it is protected from direct sunlight.
Do not use this medicine if you notice that it contains particles or if the color has changed.
For single use only.
Medicines should not be disposed of via wastewater or 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 ethyl calcium time.Parsabiv 2.5 mg solution for injection : One vial contains 2.5 mg ethyl calcium time in 0.5 ml solution (5 mg / ml).Parsabiv 5 mg solution for injection : One vial contains 5 mg ethyl calcite in 1 ml solution (5 mg / ml).Parsabiv 10 mg solution for injection : One vial contains 10 mg of ethyl calcite in 2 ml solution (5 mg / ml).
- The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide (see section 2: Parsabiv contains sodium ).
What the medicine looks like and the contents of the pack
Parsabiv is a clear and colorless liquid.
Parsabiv is a solution for injection in a vial.
Pack sizes of 1, 6, 12, and 42 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands