Dexaven

Package Leaflet: Information for the Patient

Dexaven, 4 mg/ml, Solution for Injection

Dexamethasone phosphate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Dexaven and what is it used for
• 2. Important information before using Dexaven
• 3. How to use Dexaven
• 4. Possible side effects
• 5. How to store Dexaven
• 6. Contents of the pack and other information

1. What is Dexaven and what is it used for

The solution for injection Dexaven contains dexamethasone phosphate, in the form of a well-soluble sodium phosphate dexamethasone in water and body fluids. Dexamethasone is a synthetic glucocorticosteroid (a type of adrenal cortex hormone). It has a very strong and long-lasting anti-inflammatory, anti-allergic, and immunosuppressive effect, but it does not have a mineralocorticoid effect (hormonal effect on mineral components of the body).

Indications for use:

• Treatment of acute life-threatening conditions that require the administration of glucocorticosteroids (including shock of various etiology, brain edema, laryngeal and vocal cord edema, acute allergic reactions, severe bronchospastic conditions, such as status asthmaticus, bronchitis in the course of infection, chronic bronchitis, Addison's disease crisis).
• Clinical situations that require the use of glucocorticosteroids for the treatment and/or alleviation of symptoms of the underlying disease or its complications.
• Prevention of nausea and vomiting induced by chemotherapy or radiotherapy, as well as other adverse effects and complications associated with anti-cancer therapy that can be prevented or alleviated by the administration of glucocorticosteroids.
• Prevention and treatment of complications of surgical procedures, including mainly nausea and vomiting, which can be prevented or alleviated by the administration of glucocorticosteroids.
• Dexaven is used in the treatment of COVID-19 in adult patients and adolescents (12 years of age or older with a body weight of at least 40 kg) who require oxygen therapy.

2. Important information before using Dexaven

When not to use Dexaven

• intramuscularly, if you have idiopathic thrombocytopenic purpura;
• intra-articularly, in cases where you have:
• infection in or near the joint, requiring treatment,
• bacterial arthritis,
• joint instability requiring treatment,
• bleeding disorders (spontaneous or caused by anticoagulant medications),
• periarticular calcification,
• aseptic necrosis of bone,
• tendon rupture,
• Charcot's joint.
• locally without additional causal treatment in case of infections at the injection site.

In acute life-threatening conditions, there are no contraindications to the use of Dexaven, especially if it is intended to be used for a short time (24-36 hours).

Warnings and precautions

Do not stop taking any other steroid medicines without consulting your doctor.
Dexamethasone should not be given to patients with COVID-19 who do not require oxygen or mechanical ventilation, due to the lack of therapeutic benefits and the risk of worsening the condition in this patient group.
Before starting treatment with Dexaven, discuss it with your doctor, pharmacist, or nurse.
General precautions for the use of steroid medicines in certain diseases, masking of infections, concomitantly used medicines, etc. in accordance with current recommendations.
The medicine should only be used in the manner and in the doses prescribed by the doctor.
During treatment with Dexaven, psychological disorders may occur, from euphoria, insomnia, mood and personality changes, severe depression to psychotic symptoms. You should inform your doctor about any history of or existing: emotional instability, psychotic tendencies, or past illnesses, such as depression or manic-depressive syndrome. Symptoms accompanying these conditions may worsen under the influence of Dexaven.
Glucocorticosteroids may mask some symptoms of inflammation, and during their use, new infections may develop. During the use of glucocorticosteroids, the body's immunity may be reduced, and there may be difficulties in localizing the infection.
You should not be vaccinated while taking this medicine, as immune reactions are weakened, and antibody production may be impaired.
You should inform your doctor about past infectious diseases, such as chickenpox, measles, and vaccinations received, as well as in case of exposure to any of these diseases.
During treatment with dexamethasone, you should avoid exposure to viral diseases (chickenpox, measles), especially if you have not had these diseases in the past.
During treatment, you should undergo frequent clinical monitoring of your health in the following cases:

• bacterial infection;
• active or latent peptic ulcer;
• osteoporosis (especially in postmenopausal women);
• hypertension;
• congestive heart failure;
• diabetes;
• ongoing or past severe manic-depressive psychosis (especially past poststeroid psychosis);
• past tuberculosis;
• glaucoma (also if the disease occurs in the family);
• liver damage or cirrhosis;
• renal failure;
• epilepsy;
• ulceration of the mucous membrane of the gastrointestinal tract;
• recent intestinal anastomosis;
• predisposition to venous thrombosis;
• ulcerative colitis;
• diverticulitis;
• myasthenia (rapid fatigue and muscle weakness);
• ophthalmic herpes threatening corneal perforation;
• hypothyroidism.

After administration of Dexaven, severe allergic reactions may occur, such as laryngeal edema, urticaria, bronchospasm, especially in patients who have had allergic reactions in the past.
Intra-articular administration of Dexaven increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in stressed joints may lead to worsening of degenerative joint changes. One of the possible causes is overloading of the affected joint after the pain or other symptoms have subsided.
If you experience blurred vision or other vision disturbances, you should contact your doctor.
You should consult your doctor if you experience symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, as well as shallow breathing, if you have a hematological malignancy.
Caution should be exercised when using Dexaven in children.
Close monitoring of growth and development in children is recommended during long-term use of glucocorticosteroids.
Available data indicate the occurrence of long-term adverse events affecting neurological development in preterm infants with chronic lung disease after early treatment (<96 hours) with an initial dose of 0.25 mg kg body weight twice daily.
If dexamethasone is administered to a preterm infant, it is necessary to monitor heart function and structure.
Adverse reactions occurring after the use of glucocorticosteroids may have a more severe course in elderly patients, especially regarding osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infections, and skin thinning.

Dexaven and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Some medicines may enhance the effect of Dexaven, and your doctor may want to monitor your condition closely when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
In case of need for administration of dexamethasone in the form of injections in acute life-threatening conditions, especially if it is intended to be used for a short time, interactions with other medicines are not taken into account.
If dexamethasone is used for a long time, the effect of other medicines used at the same time may be weakened or enhanced.
Acceleration of dexamethasone metabolism and consequently a decrease in its therapeutic effect may occur when used concomitantly with:

• phenobarbital (a sleeping pill);
• rifampicin (an anti-tuberculosis medicine);
• rifabutin (a bactericidal medicine);
• carbamazepine (a medicine used to treat epilepsy);
• phenylbutazone (a medicine with anti-inflammatory and analgesic effects);
• phenytoin (an antiepileptic and antiarrhythmic medicine);
• primidone (a medicine used to treat epilepsy);
• aminoglutethimide (a medicine used in cancer treatment);
• ephedrine (a component of cold medicines).

The effect of dexamethasone may be increased by concomitant use of:

• estrogens (female sex hormones);
• oral contraceptives;
• medicinal products containing substances that inhibit CYP3A4, such as ketoconazole and itraconazole (medicines used to treat fungal infections).

Dexamethasone increases:

• potassium loss when used concomitantly with acetazolamide (a medicine used to treat glaucoma, epilepsy), carbenoxolone (a medicine used to treat peptic ulcer disease), diuretics, and laxatives;
• toxicity of concomitantly used cardiac glycosides;
• the risk of edema when used concomitantly with anabolic steroids;
• the adverse effect of non-steroidal anti-inflammatory medicines, especially their effect on the gastrointestinal tract;
• renal clearance of salicylates.

Dexamethasone decreases:

• the concentration of non-steroidal anti-inflammatory medicines in serum, thereby reducing their effectiveness;
• the body's response to vaccines and anatoxins by inhibiting the immune system;
• by half the concentration of praziquantel (a medicine used to treat parasitic infections) in serum. Dexamethasone decreases (less often increases) the effect of coumarin derivatives (oral anticoagulants), which requires a corresponding change in their dosage. After the use of corticosteroids with protirelin, the increase in TSH level after protirelin administration may be reduced.

Fluoroquinolones (a group of antibiotics) may increase the risk of tendon disorders.

Pregnancy, breastfeeding, and fertility

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 using this medicine.
Pregnancy
The medicine should only be used in pregnancy if the doctor considers that the benefits to the mother outweigh the risks to the fetus. Newborns born to mothers who received significant doses of dexamethasone during pregnancy should be kept under observation due to the risk of adrenal insufficiency.
In newborns of mothers who received Dexaven at the end of pregnancy, low blood sugar may occur after birth.
Breastfeeding
Glucocorticosteroids pass into breast milk and may impair growth, endogenous production of glucocorticosteroids, and cause other adverse effects in newborns and infants. Breastfeeding should be discontinued during treatment with this medicine.
Fertility
There is no data on the effect of dexamethasone on fertility in humans.

Driving and using machines

Dexaven has no or negligible influence on the ability to drive and use machines.
Dexaven contains0.1 mg of benzalkonium chloride per 1 ml of product, which corresponds to 0.1 mg/1 ml in Dexaven 4 mg/ml and 0.2 mg/2 ml in Dexaven 8 mg/2ml.
Dexaven containsless than 1 mmol (23 mg) of sodium per ampoule (1 ml and 2 ml), i.e., the medicine is considered "sodium-free".

3. How to use Dexaven

This medicine should always be used exactly as your doctor has told you. Your doctor will decide how long you should use dexamethasone. If you are not sure, ask your doctor.
The medicine is administered by intravenous injection, intramuscular injection, or intravenous infusion.
Intramuscular injection should be deep, into a large muscle mass. The medicine can also be administered locally or intra-articularly. The injection should be performed slowly.
Immediately before administration in an infusion, the contents of the ampoule are diluted with isotonic sodium chloride solution (0.9%) or 5% glucose solution.
It is necessary to take into account the additional sodium content of the diluent.
The duration of treatment depends on the indications and is determined by the doctor.
The doctor will determine an individual treatment schedule for each patient, depending on the severity of the disease, the patient's response to treatment, and specific situations (e.g., stress in the patient), which must be strictly followed.
Usually, the initial doses are higher. After achieving the desired therapeutic effect, the dose is reduced until the smallest dose that maintains the beneficial therapeutic effect is established, or until the medicine is discontinued.
Adults
Unless otherwise prescribed, the recommended dose is 4 to 16 mg/day; exceptionally up to 32 mg/day.
Usually, a single dose is 4 to 8 mg.
If necessary, the dose can be repeated at suitable intervals, several times a day.
However, in life-threatening situations (e.g., anaphylactic shock, acute asthma attack), much higher doses may be needed.
Treatment of brain edema: a dose of 10 mg should be administered intravenously, followed by 4 mg intramuscularly every 6 hours, until symptoms subside. A response is usually obtained within 12-24 hours.
After 2-4 days, the dosage may be reduced, and after 5-7 days, it may be gradually discontinued.
For the treatment of COVID-19
In the treatment of COVID-19, a dose of 6 mg per day should be administered intravenously for up to 10 days.
In adolescents (12 years of age or older), it is recommended to administer 6 mg intravenously once a day for up to 10 days.
Treatment involving local injection usually requires a dose of 4 to 8 mg. A dose of 2 mg is sufficient in the case of injection into small joints.
In the prevention of nausea and vomiting induced by chemotherapy or radiotherapy, as well as other adverse effects and complications associated with anti-cancer therapy, the optimal dose of dexamethasone has not been established. Usually, 8 to 20 mg is administered intravenously before chemotherapy. In some cases, an additional dose of intravenous or oral dexamethasone was administered after 24-72 hours. The medicine should be used in accordance with the dosing specified in the chemotherapy protocols.
In the prevention and treatment of complications of surgical procedures, including mainly nausea and vomiting, the recommended dose is 4 to 5 mg of dexamethasone administered intravenously. The dosage will be determined by the doctor, depending on the patient's condition.
Use in children and adolescents
Dosing requirements are variable and may be changed depending on the individual needs of the patient. Usually, 0.2 to 0.4 mg/kg body weight per day.
After long-term use, the medicine should be discontinued gradually.

Use in elderly patients

Adverse reactions occurring after the use of glucocorticosteroids may have a more severe course in elderly patients, especially regarding osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infections, and skin thinning.
To avoid life-threatening reactions, such patients should be given special care.

Use of a higher than recommended dose of Dexaven

In case of use of a higher dose than recommended, you should immediately consult a doctor.

Missing a dose of Dexaven

You should not take a double dose to make up for a missed dose.

Stopping the use of Dexaven

The medicine should always be used in accordance with the scheme prescribed by the doctor. Do not stop using Dexaven without consulting your doctor, as sudden discontinuation of treatment may be life-threatening.
You should not stop taking systemic corticosteroids in patients who are already being treated with systemic (oral) corticosteroids for other reasons (e.g., patients with chronic obstructive pulmonary disease (COPD)) but do not require oxygen supplementation.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine is well tolerated when used for a short time, and it is unlikely that side effects will occur, which have been reported during long-term treatment.
However, you should always consider the possibility of side effects caused by the use of glucocorticosteroids.
Side effects of unknown frequency (frequency cannot be estimated from the available data):

Musculoskeletal and connective tissue disorders:aseptic necrosis of the femoral and humeral head, muscle weakness, steroid myopathy, muscle mass loss, osteoporosis, spontaneous fractures, including compression fractures of the spine and pathological fractures of long bones.

Gastrointestinal disorders:nausea, vomiting, loss of appetite, which may cause weight loss, increased appetite, which may lead to weight gain, diarrhea or constipation, abdominal distension, stomach irritation, and esophageal inflammation with ulcers, gastric ulcer with possible perforation and bleeding, perforation of the small and large intestine, especially in inflammatory bowel diseases, pancreatitis.

Skin and subcutaneous tissue disorders:impaired wound healing, skin thinning, which becomes sensitive and prone to damage, bruising and bleeding, facial flushing, striae, hirsutism (excessive male-type hair growth in women), acne-like eruptions, decreased skin test reactivity, hypersensitivity reactions such as allergic dermatitis, urticaria, angioedema.

Treatment with glucocorticosteroids administered parenterally causes hypo- or hyperpigmentation (decrease or increase in skin pigmentation), scleroderma, skin thickening, decreased pain sensation, skin or subcutaneous tissue atrophy, and sterile abscesses at the injection site.

Nervous system disorders:seizures, neuritis, paresthesia, after discontinuation of glucocorticosteroids, an increase in intracranial pressure with papilledema (pseudotumor cerebri) may occur.

Endocrine disorders:menstrual disorders, symptoms of Cushing's syndrome, growth retardation in children, secondary adrenal insufficiency, decreased glucose tolerance, manifestation of latent diabetes, and increased insulin or oral hypoglycemic requirements in diabetic patients.

Eye disorders:increased intraocular pressure, secondary glaucoma, exophthalmos, optic nerve damage, posterior subcapsular cataract, vision disturbances, loss of vision, blurred vision, worsening of viral or fungal eye disease.

Metabolic and nutritional disorders:negative nitrogen balance due to increased protein catabolism, sodium retention, fluid retention, potassium loss, hypokalemic alkalosis, hypocalcemia.

Psychiatric disorders:dizziness and headaches, hallucinations, psychoses, euphoria, mood changes, symptoms of pseudotumor cerebri caused by increased intracranial pressure and the occurrence of papilledema.

Vascular disorders:thromboembolism, fat embolism, hypercholesterolemia, accelerated atherosclerosis, necrotizing vasculitis, venous thrombosis.

Cardiac disorders:arrhythmias or ECG changes associated with potassium deficiency, syncope, exacerbation of hypertension, heart rupture as a consequence of recent myocardial infarction, sudden cardiac arrest, congestive heart failure, hypertension, thickening of the heart muscle (hypertrophic cardiomyopathy) in preterm infants, which usually returns to normal after discontinuation of treatment.

Blood and lymphatic system disorders:leukocytosis, thrombocytopenia, lymphopenia.

General disorders and administration site conditions:exacerbation or masking of infection symptoms, insomnia, anaphylactic reactions, burning and tingling, which may occur after intravenous administration of glucocorticosteroids.

Withdrawal syndrome

Occurs after sudden discontinuation of dexamethasone after long-term use. It is caused by acute adrenal insufficiency and may be life-threatening. The withdrawal syndrome may also include: muscle pain, joint pain, fever, rhinitis, conjunctivitis, painful skin nodules, and weight loss.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexaven

Store in a temperature below 25°C. Store in the original package to protect from light.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
After dilution in infusion fluids (see section 6.6 of the characteristics), chemical and physical stability has been demonstrated for 24 hours at a temperature of 25°C. For microbiological reasons, the product should be used immediately, unless the opening/dilution method prevents the risk of microbial contamination. If the product is not used immediately, the user is responsible for the storage time and conditions.

6. Contents of the pack and other information

What Dexaven contains

• The active substance of the medicine is dexamethasone phosphate (in the form of dexamethasone sodium phosphate). 1 ml of solution contains 4 mg of dexamethasone phosphate.
• The other ingredients are: benzalkonium chloride, disodium edetate, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections, nitrogen.

What Dexaven looks like and contents of the pack

Dexaven is a colorless or light yellow, clear solution.
The pack contains: ampoules made of orange glass in a cardboard box.
5 ampoules of 1 ml
10 ampoules of 1 ml
10 ampoules of 2 ml

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
58-500 Jelenia Góra, ul. Wincentego Pola 21

Date of last revision of the leaflet: