VIZAMYL – Flutemetamol uses, dose and side effects

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Contents hide
1 What VIZAMYL is and what it is used for
2 What you need to know before you receive VIZAMYL
3 VIZAMYL must not be used:
4 Warnings and precautions
5 Children and young people
6 Other medicines and VIZAMYL
7 Pregnancy and breastfeeding
8 Driving ability and use of machinery
9 VIZAMYL contains alcohol (ethanol) and sodium
10 How VIZAMYL is used
11 If you have received too much VIZAMYL
12 4. Possible side effects
13 5. How VIZAMYL should be stored
14 Contents of the packaging and other information
15 Contents declaration
16 Appearance and package sizes of the medicine
17 Marketing authorization holder and manufacturer

400 MBq/ml solution for injection,
flutemetamol ( 18 F)

What VIZAMYL is and what it is used for

VIZAMYL contains the active substance flutemetamol ( 18 F) and is used to help diagnose Alzheimer’s disease and other causes of memory loss. This medicine is a radiopharmaceutical product used to make a diagnosis.

VIZAMYL is used to help diagnose Alzheimer’s disease and other causes of memory loss and is given to adults with memory problems before they undergo a type of brain scan called positron emission tomography (PET scan). This exam, combined with other brain function tests, can help your doctor determine whether you may have beta-amyloid plaques in your brain. Beta-amyloid plaques are deposits that are sometimes present in the brains of people with dementia (such as Alzheimer’s disease ).

You should discuss the results of the examination with the doctor who ordered the scan.

The use of Vizamyl involves exposure to small amounts of radioactivity.

The doctor and the nuclear medicine physician have judged that the benefit of the examination with the radioactive substance outweighs the risk of being exposed to these small amounts of radiation.

What you need to know before you receive VIZAMYL  

VIZAMYL must not be used: 

– If you are allergic to flutemetamol ( 18 F) or any other ingredient in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before receiving VIZAMYL if you:

  • have kidney problems
  • have liver problems
  • are pregnant or think you may be pregnant
  • breastfeeding.

Children and young people

VIZAMYL is not intended for children and adolescents under the age of 18.

Other medicines and VIZAMYL

Tell the nuclear medicine doctor if you are taking, have recently taken, or might be taking any other medicines as they may affect the images obtained from the brain scan.

Pregnancy and breastfeeding

You must tell the isotope doctor before receiving VIZAMYL if there is any possibility that you are pregnant, if you have missed your period or if you are breastfeeding. If you are unsure, you must discuss it with the isotope doctor who will lead the examination.

If you are pregnant

The isotope doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risks.

If you are breast-feeding

You must take a break from breastfeeding for 24 hours after injection one. Express the breast milk during this period and discard it. Ask the radiologist for advice before receiving this medicine.

You should avoid close contact with small children for 24 hours after injection a.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your nuclear medicine physician before receiving this medicine.

Driving ability and use of machinery

VIZAMYL can cause transient dizziness which may affect your ability to drive or use machines. You should avoid driving, operating machinery, or engaging in other risky activities until these effects have completely worn off.

VIZAMYL contains alcohol (ethanol) and sodium

This medicine contains alcohol ( ethanol ). Each dose contains up to 552 mg of alcohol, equivalent to approximately 14 ml of beer or 6 ml of wine. This can be harmful to people who are addicted to alcohol. It should be considered for pregnant and lactating women as well as people with liver problems or epilepsy.

VIZAMYL contains a maximum of 41 mg sodium (the main component of table salt) per dose. This corresponds to about 2% of the WHO’s highest recommended daily intake of sodium. This should be taken into account by patients prescribed a low-salt diet.

How VIZAMYL is used

There are strict regulations on the use, handling, and destruction of radiopharmaceuticals.

VIZAMYL will only be used in specially controlled areas. This product is handled and given to you by people who are trained and qualified to use it safely. They will provide you with the necessary information regarding the examination.

Your isotope doctor may ask you to drink plenty of water before the examination time and for 24 hours after the study to urinate as often as possible, which will help you remove the medicine from your body.

Dose 

The isotope doctor who conducts the examination decides how much VIZAMYL you will receive. The doctor will use the smallest amount needed.

The amount most often recommended for an adult is 185 MBq (megabecquerel, the unit used to measure radioactivity).

How VIZAMYL is given and how the examination is carried out

VIZAMYL is given as an injection into a vein ( intravenous injection ), accompanied by saline so that the entire dose is delivered safely.

One injection is enough for the examination that your doctor needs.

Duration of the survey

After a VIZAMYL injection, it takes about 90 minutes before a brain scan can be done. The Isotope doctor will inform you of how long the examination usually lasts.

After you have had a VIZAMYL injection, you should: 

Avoid close contact with small children and pregnant women for 24 hours after injection a.

The isotope doctor will tell you if you need to take any special precautions while receiving this medicine. Contact the isotope doctor if you have any questions

If you have received too much VIZAMYL

It is unlikely that you will get an overdose because you will only be given one dose of VIZAMYL by the isotope doctor under controlled conditions.

If an overdose should nevertheless occur, you will receive appropriate treatment. The treatment involves speeding up the passage of urine and feces, so that the radioactivity disappears as quickly as possible from your body.

If you have any further questions about VIZAMYL, contact the isotope doctor who is conducting the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Serious side effects are

Tell your doctor straight away if you notice any of the following as you may need urgent medical treatment:

  • Allergic reactions – symptoms may include swelling of the face or eyes, pale, itchy, or tight skin or rash, shortness of breath, chest tightness, throat irritation, or vomiting. These side effects are less common and may occur in up to 1 in 100 users.

Tell the doctor immediately if you notice any of the above signs. 

Other side effects ar

Common – may affect up to 1 in 10 users

  • Redness
  • Increased blood pressure

Uncommon – may affect up to 1 in 100 users. You may experience the following less common side effects:

  • Headache
  • Dizziness
  • Feeling of worry
  • Nausea
  • Chest discomfort
  • Low blood sugar (symptoms: hunger and headache)
  • Back pain
  • Feeling feverish or feeling frozen
  • Increased respiratory rate
  • Pain at the injection site
  • Pounding heart (palpitations)
  • Pain in muscles or bones
  • Tremors ( tremors )
  • Swollen skin
  • Fever
  • Increased breathing ( hyperventilation )
  • Taste changes
  • Feeling of dizziness
  • Impaired sensation or feeling of numbness
  • Fatigue or weakness
  • Inability to get or maintain an erection
  • Indigestion, stomach ache, or sore mouth
  • Vomiting
  • Decreased sensation or sensitivity, especially in the skin or face
  • Elevated values ​​for lactate dehydrogenase or neutrophils in blood samples
  • Tightening skin

This radiopharmaceutical emits low amounts of ionizing radiation, which is associated with a very low risk of cancer and gene defects (ie, genetic disorders).

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Swedish Medicines Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase information about drug safety. Postal address

5. How VIZAMYL should be stored

You do not need to store this medicine yourself. The isotope doctor is responsible for the medicine being stored in a suitable place. Storage of radiopharmaceuticals takes place by national regulations on radioactive materials.

The following information is only intended for the isotope doctor.

VIZAMYL must not be used after the expiry date which is stated on the label of the protective container after “Exp.date.”

VIZAMYL should not be used if the bottle is not intact or if the solution contains particles or is discolored.

Contents of the packaging and other information

Contents declaration

  • The active substance is flutemetamol ( 18 F). 1 ml of solution contains flutemetamol ( 18 F) 400 MBq at the day and time of calibration.
  • The other ingredients are sodium chloride and anhydrous ethanol, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, and water for injections, see section 2.

Appearance and package sizes of the medicine

  • VIZAMYL is a clear, colorless slightly yellow solution for injection.
  • VIZAMYL is supplied in a 10 ml or 15 ml glass vial stored in a container.
  • Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

GE Healthcare AS

Nycoveien 1,
NO-0485 Oslo

Norway

Manufacturer

MAP Medical Technologies Oy

Saukonpaadenranta 2

Helsinki, FI-00180

Finland

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