Parsabiv

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

etelcalcetide hydrochloride

Tillgänglig från:

Amgen Europe B.V.

ATC-kod:

H05BX04

INN (International namn):

etelcalcetide

Terapeutisk grupp:

Anti-parathyroid agents, Calcium homeostasis

Terapiområde:

Hyperparathyroidism, Secondary

Terapeutiska indikationer:

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

Produktsammanfattning:

Revision: 9

Bemyndigande status:

Authorised

Tillstånd datum:

2016-11-11

Bipacksedel

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARSABIV 2.5 MG SOLUTION FOR INJECTION
PARSABIV 5 MG SOLUTION FOR INJECTION
PARSABIV 10 MG SOLUTION FOR INJECTION_ _
ETELCALCETIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Parsabiv is and what it is used for
2.
What you need to know before you use Parsabiv
3.
How to use Parsabiv
4.
Possible side effects
5.
How to store Parsabiv
6.
Contents of the pack and other information
1.
WHAT PARSABIV IS AND WHAT IT IS USED FOR
Parsabiv contains the active substance etelcalcetide, which reduces
parathyroid hormone known as
PTH.
Parsabiv is used to treat secondary hyperparathyroidism in patients
with serious kidney disease who
need haemodialysis to clear their blood of waste products.
In secondary hyperparathyroidism too much PTH is produced by the
parathyroid glands (four small
glands in the neck). “Secondary” means that the
hyperparathyroidism is caused by another condition,
e.g. kidney disease. Secondary hyperparathyroidism can cause the loss
of calcium from the bones,
which can lead to bone pain and fractures and problems with blood and
heart vessels. By controlling
the levels of PTH, Parsabiv helps to control calcium and phosphate in
your body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARSABIV
DO NOT USE PARSABIV
-
if you are allergic to etelcalcetide or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have very low levels of calcium in your blood. Your doctor will
monitor your blood
calcium levels.
WARNINGS AND PRECAUTIONS
Before you are given Parsabiv, tell your doctor if you have or have
ever had:

heart problems, such as heart failure or arrhythmia

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Parsabiv 2.5 mg solution for injection
Parsabiv 5 mg solution for injection
Parsabiv 10 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Parsabiv 2.5 mg solution for injection
Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5
mL of solution.
Each mL contains 5 mg etelcalcetide.
Parsabiv 5 mg solution for injection
Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of
solution.
Each mL contains 5 mg etelcalcetide.
Parsabiv 10 mg solution for injection
Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL
of solution.
Each mL contains 5 mg etelcalcetide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Parsabiv is indicated for the treatment of secondary
hyperparathyroidism (SHPT) in adult patients with
chronic kidney disease (CKD) on haemodialysis therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended initial dose of etelcalcetide is 5 mg administered by
bolus injection 3 times per
week. Corrected serum calcium should be at or above the lower limit of
the normal range prior to
administration of first dose of Parsabiv, a dose increase, or
reinitiation after a dose stop (see also dose
adjustments based on serum calcium levels). Parsabiv should not be
administered more frequently than
3 times per week.
_Dose titration_
Parsabiv should be titrated so that doses are individualised between
2.5 mg and 15 mg. The dose may
be increased in 2.5 mg or 5 mg increments no more frequently than
every 4 weeks to a maximum dose
of 15 mg 3 times per week to achieve the desired parathyroid hormone
(PTH) target.
3
_Dose adjustments based on PTH levels_
PTH should be measured after 4 weeks from initiation or dose
adjustment of Parsabiv, and
approximately every 1-3 months during maintenance. Dose adjustment may
be necessary at any time
during