Argipressin Vantage 20 IU/ml solution for injection – patient leaflet, side effects, dosage

1. What Argipressin Vantage is and what it is used for

Argipressin Vantage contains argipressin which is similar to a naturally occurring hormone in your body. It is an antidiuretic which helps to prevent excess loss of water in your urine and also narrows some blood vessels in the body.

Argipressin Vantage is used to treat:

• diabetes insipidus. This is a rare form of

  diabetes causing production of large quantities of urine. Argipressin Vantage increases the amount of water absorbed back into your kidneys.

• bleeding from enlarged veins in the

  oesophagus (food pipe).

• adults with septic shock who have low

  blood pressure despite treatment with fluids and norepinephrine.

2. What you need to know before you use Argipressin Vantage

Do not use Argipressin Vantage

• if you are allergic to argipressin or any

  of the other ingredients of this medicine (listed in section 6).

• if you suffer from a certain type of kidney

  disease called chronic nephritis with nitrogen retention (your doctor will advise you).

• if you suffer from any diseases or conditions

  associated with your blood vessels, especially the blood vessels of your heart.

• if you are intended to receive halogenated

  anaesthetic agents such as halothane, isoflurane, enflurane, desflurane, and sevoflurane.

Talk to your doctor if any of these conditions applies to you before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are given Argipressin Vantage:

• if you suffer from asthma or other allergic

  condition

• if you suffer from migraine
• if you suffer from epilepsy (fits)

• if you suffer from high blood pressure,

  heart disease

• if you suffer from obstruction of the blood

  vessels of the heart (e.g. coronary artery)

For the treatment of septic shock, Argipressin Vantage may be given only if other measures (fluid substitution and blood pressure raising medicines called catecholamines) do not work.

While you are treated with Argipressin Vantage, your condition may need to be closely monitored:

• you may need regular blood tests and electrocardiogram recording;
• your skin may be monitored for the signs of insufficient blood flow (pallor, cold, pain, abnormal sensations);
• you may be observed for the signs of possible fluid retention (drowsiness, sleepiness, headache, and in severe cases – coma and convulsions).

Children

Argipressin Vantage is not recommended for children and adolescents below 18 years old.

Other medicines and Argipressin Vantage

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following medicines:

• medicines suspected of causing the syndrome of inappropriate antidiuretic hormone secretion, e.g., medicines which control seizures (carbamezepine, felbamate)

• other medicines used to treat diabetes

  (chloropropamide)

• lipid lowering agent (clofibrate)

• medicines used to treat depression

  (e.g. amitriptyline, fluoxetine, paroxetine, sertraline, escitalopram, citalopram) or psychiatric disorders (haloperidol)

• medicine used in corticosteroid

  replacement therapy (fludrocortisone)

• medicines containing urea (in some skin and ear preparations)
• medicines suspected of causing diabetes insipidus, e.g., antibiotics (demeclocycline)
• medicines used to treat mania (lithium) or other psychiatric disorders (clozapine)
• medicines used to treat HIV infection, cytomegalovirus and herpes viruses (foscarnet).
• anti-inflammatory drug (indomethacin)
• a loop diuretic (furosemide) used to treat fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome.
• ganglionic blockers used to produce controlled hypotension during surgical procedures and in hypertensive crises.
• other medicines used to treat severely low blood pressure or cardiac arrest called cathecholamines (e.g., norepinephrine).

Argipressin Vantage with alcohol

Do not drink alcohol before you are given Argipressin Vantage. Alcohol may block the activity of Argipressin Vantage.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of Argipressin Vantage during pregnancy and breast-feeding is not recommended unless your doctor thinks it is essential. If breast-feeding is necessary, discard the breast milk for 1.5 hours after receiving Argipressin Vantage.

This medicine has impaired male fertility in several animal studies. The impact on human fertility is not known.

Driving and using machines

Argipressin Vantage can affect your ability to drive and use machines safely, as you may feel dizzy after receiving your injection. Talk to your doctor for further advice.

3. How to use Argipressin Vantage

It is most likely that you will be in hospital when you are given Argipressin Vantage.

For the treatment of diabetes insipidus: The medicine will be injected under the skin or into a muscle every four hours. Your doctor will decide on the most suitable dose and

The following information is intended for healthcare professionals only

Method of administration:

Argipressin Vantage 20 IU/mL solution for injection must be diluted prior to intravenous administration.

For the treatment of variceal bleeding, dilute 20 IU (1 ml) of Argipressin Vantage in 100 ml of 5% glucose solution.

For the treatment of septic shock, dilute Argipressin Vantage with 0.9% sodium chloride or 5% glucose solution (the volume

of diluent depends on patient’s fluid status):

• if patient is not fluid restricted -

  to 0.1 IU/ml (mix 50 IU [2.5 mL] of Argipressin Vantage with 500 mL of diluent);

• if patient is fluid restricted - to 1 IU/ml

  (mix 100 IU [5 mL] of Argipressin Vantage with 100 mL of diluent).

Paediatric population

Argipressin Vantage is not recommended in children and adolescents under 18 years old.

way to give it to you depending on your symptoms.

For the treatment of bleeding in the oesophagus: The medicine is diluted in a sugar solution and slowly dripped through a needle into a vein. Your doctor will decide on the most suitable dose and way to give it to you depending on your symptoms.

For the treatment of septic shock: The medicine is administered as a long-term infusion diluted in a sugar or physiological saline solution and slowly dripped through a needle into a vein. Your doctor will decide on the most suitable dose and way to give it to you depending on your symptoms.

If you think you have been given more Argipressin Vantage than you should have

As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary. However, if you think that you have been given too much, tell your doctor immediately. If you experience chest pain after receiving this medicine, inform your doctor immediately.

If you have any further questions on the use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reaction. If any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) have occurred, contact a doctor immediately as this can also result in a heart attack if not treated straight away.

Argipressin Vantage can cause ‘water intoxication’. Signs of this are drowsiness, being uninterested in anything (listless) and headaches. If you notice any of these signs, tell the nurse or your doctor straightaway. If it is not corrected, water intoxication can lead to fits or even coma.

The frequency of the listed side effects is not known (cannot be estimated from the available data). You may have any of the following side effects:

• low sodium levels in the blood

  (hyponatremia)

• excessive amount of water in your body

  (water intoxication)

• condition of reduced tissue perfusion,

  resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function (hemorrhagic shock)

• decreased platelets in the blood
• uncontrolled bleeding

• allergic/anaphylactic reactions (including

  shock) can occur in sensitive patients.

• headache
• dizziness
• chest pain due to angina
• loss of heart function (cardiac arrest)
• heart failure

• irregular and rapid heart rhythm (atrial

  fibrillation)

• slow heart rhythm (bradycardia)

• restricted blood flow in heart tissues

  (myocardial ischemia)

• pallor

• restricted blood supply in your limbs

  (peripheral vascular ischemia) including tissue death (gangrene) in single cases

• shortness of breath
• flatulence
• nausea
• vomiting
• diarrhoea
• abdominal pain
• urgency to pass stools

• insufficient blood supply to small intestine

  (mesenteric ischemia)

• increased bilirubin levels in the blood
• tissue death (gangrene)
• excessive sweating
• hives (urticaria)

• lesions caused by blockage of blood supply

  (ischemic lesions)

• swelling (fluid retention)

• acute kidney insufficiency

  If any of these side effects occur you should stop treatment immediately and contact your doctor.

  Reporting of side effects

  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

  Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

  By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Argipressin Vantage

Keep this medicine out of the sight and reach of children.

Unopened: Store in the refrigerator (2°C – 8°C). Do not freeze.

After the first opening: dilute further immediately.

After dilution of 20 IU (1 ml) of Argipressin Vantage in 100 ml of 5% glucose:

for immediate use.

After dilution with 0.9 % sodium chloride or 5% glucose solution to either 0.1 units/mL or 1 unit/mL:

Chemical and physical in-use stability after dilution has been demonstrated for 18 hours at room temperature or 24 hours at 2 °C – 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Argipressin Vantage contains

• The active substance is argipressin. One ampoule with 1 ml solution contains 20 IU of argipressin (as acetate).
• The other ingredients are acetic acid, water for injection.

What Argipressin Vantage looks like and contents of the pack

Clear, colourless liquid, free from the visible particles.

Each ampoule contains 1 ml of solution. Carton box contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vantage Pharmaceuticals Ltd.

Ravalco House, Cleveland Way,

Hemel Hempstead, Hertfordshire

HP2 7DL

United Kingdom

Manufacturer

Cubic Pharmaceuticals Limited

Unit 3, Sextant Park, Neptune Close, Medway City Estate, Rochester, Kent ME2 4LU United Kingdom

This leaflet was last revised in January 2025

Elderly

Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

Patients with hepatic impairment

As no clinical studies have been carried out in patients with hepatic impairment, the treatment recommendations are not established for patients with hepatic impairment.

Patients with renal impairment

As no clinical studies have been carried out in patients with renal impairment, the treatment recommendations are not established for patients with renal impairment.

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