15 micrograms/ml solution for injection
desmopressin acetate
What Octostim is and what it is used for
The active substance in Octostim acts like the natural hormone et vasopressin and increases the levels of factor VIII and von Willebrand factor in the blood, which is necessary for the blood to coagulate.
Octostim is used to shorten or normalize prolonged bleeding time in patients with impaired platelet function (platelet dysfunction), urinary intoxication ( uremia ), or cirrhosis ( liver cirrhosis ) and in patients with prolonged bleeding time without a known cause. It is also used to prevent bleeding associated with minor surgery in patients with mild forms of hemophilia type A, who have a lack of coagulation factor VIII in the blood, as well as in patients with von Willebrand’s disease (except type IIB).
The desmopressin contained in Octostim may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Octostim
Do not use Octostim
- if you are allergic to desmopressin acetate or any of the other ingredients of this medicine (listed in section 6)
- if you have an abnormally large fluid intake ( polydipsia )
- if you have angina in the heart ( unstable angina pectoris)
- in disease states that require treatment with diuretics (eg heart failure )
- if you have moderate to severe renal impairment
- if you have low sodium in your blood
- if you have disrupted hormone secretion (so-called SIADH)
- if you have von Willebrand’s type IIB disease
Warnings and cautions
Talk to your doctor or nurse before receiving Octostim
- disturbed balance of fluid and / or salts in the body
- risk of fluid accumulation in the brain
You should limit fluid intake as there is a risk that an abnormal amount of fluid will remain in your body when you take Octostim. Drink as little fluid as possible, just to quench your thirst.
If fluid intake is not limited, abnormal amounts of fluid can accumulate in the body, which can lead to weight gain, nausea, vomiting, headaches, decreased sodium levels in the blood, and severe cases of seizures. Contact a doctor if you experience these side effects.
Other medicines and Octostim
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Octostim is taken with certain medicines
- epilepsy (carbamazepine)
- mental illnesses such as depression ( SSRIs , tricyclic antidepressants , chlorpromazine)
- pain and inflammation (so-called NSAIDs )
- severe pain ( opioids )
- diabetes (so-called sulphonylureas)
the risk of an abnormal amount of fluid remaining in the body may increase
Pregnancy and breastfeeding
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 limited experience of use during pregnancy.
Desmopressin passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
Octostim has no known effect on the ability to drive and use machines.
How to use Octostim
Octostim solution for injection is a medicine used in hospitals, and should only be given by qualified personnel. Your doctor will prescribe a suitable dose for you.
If you take more Octostim than you should
It is unlikely that you will receive too much as your doctor will prescribe the appropriate dose for you.
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.
If fluid intake is not restricted according to the instructions above, abnormal amounts of fluid can accumulate in the body, which can lead to weight gain, nausea, vomiting, headaches, decreased sodium levels in the blood,d and severe cases of seizures. Contact a doctor if you experience these side effects.
Common (may affect up to 1 in 10 people): Headache, stomach ache, nausea, fatigue, a transient decrease in blood pressure with palpitations and flushing at the time of injection.
Rare (may affect up to 1 in 1,000 people): Dizziness.
Very rare (may affect up to 1 in 10,000 people): Decreased sodium levels in the blood.
Has been reported (occurs in an unknown number of users): Hypersensitivity reaction with skin redness, rash, hives, swelling ( edema ) and shortness of breath, more severe hypersensitivity reactions including anaphylactic/anaphylactoid shock and reaction, myocardial infarction, angina in the heart, blood clots in the heart, or lungs, high blood pressure.
How to store Octostim
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2ºC-8ºC).
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.
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 desmopressin acetate 15 micrograms / ml corresponding to 13.4 micrograms / ml desmopressin.
- The other ingredients are sodium chloride, hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
Octostim is supplied in glass ampoules in the following pack sizes:
5 x 1 ml, 10 x 1 ml
5 x 2 ml, 10 x 2 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
040-691 69 00
Manufacturer
Ferring GmbH
Wittland 11
24109 Kiel
Germany