Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - elzonris

Document Subject

Generated Narrative: MedicinalProductDefinition mp5ac4a49a9ba51d620f11b22f100bae66

identifier: http://ema.europa.eu/identifier/EU/1/20/1504/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ELZONRIS 1 mg/mL concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5ac4a49a9ba51d620f11b22f100bae66

identifier: http://ema.europa.eu/identifier/EU/1/20/1504/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - elzonris

Attesters

What is in this leaflet

1. What ELZONRIS is and what it is used for
2. What you need to know before you are given ELZONRIS
3. How ELZONRIS is given
4. Possible side effects
5. How to store ELZONRIS
6. Contents of the pack and other information

ELZONRIS contains the active substance tagraxofusp. Tagraxofusp, an anti-cancer medicine, is made from two proteins from different sources. One of the proteins can kill cancer cells. This protein is delivered to the cancer cell by the second protein.

ELZONRIS is used to treat adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

BPDCN is a cancer of a rare type of immature immune cells called plasmacytoid dendritic cells . It can affect many organs including the skin, bone marrow, and lymph nodes.

Do not use ELZONRIS

• if you are allergic to tagraxofusp or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using ELZONRIS and during treatment if you:

• suddenly gain weight after starting treatment, have new or worsening swelling of your face, limbs or joints (oedema) or dizziness (a symptom of low blood pressure). These may be signs of a potentially life-threatening condition known as capillary leak syndrome. For more information see Capillary Leak Syndrome in section 4. - get a whistling sound during breathing (wheezing) or have difficulty breathing, hives/ rash, itching, or swelling (signs of an allergic reaction).

• have been told you have a low level of platelets in your blood (thrombocytopenia).

• have been told you have a low level of a type of white blood cell called a neutrophil (neutropenia).

• have dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or changes in heart rhythm (signs of tumour lysis syndrome).

• have abnormal liver test results (possible sign of serious liver injury).

• have hereditary fructose intolerance (HFI), a rare genetic disorder which means you can t break down sugar in foods and drinks.

• have kidney or liver problems.

• start getting headaches, or feeling confused or drowsy, or having speech, vision or memory problems.

• have been told you have cancer in your central nervous system (CNS). You may be given a different medicine to treat this.

Your doctor will monitor you and perform regular blood tests to make sure that it is safe for you to use this medicine. If you have any problems, your treatment may be temporarily stopped and started again when you feel better.

Children and adolescents ELZONRIS is not recommended for anyone under the age of 18 years. This is because there is limited information on how well it works in this age group.

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

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 for advice before taking this medicine.

You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby .

You should not breast-feed during treatment with ELZONRIS and for at least 1 week after your last dose. It is not known if ELZONRIS passes into breast-milk.

If you are a woman who can become pregnant, you will have a pregnancy test about a week before starting treatment with ELZONRIS.

You should continue to take your contraception for at least 1 week after your last dose of ELZONRIS. Talk to your doctor about the best contraception for you and before stopping your contraception.

Driving and using machines Tagraxofusp is unlikely to affect your ability to drive or use machines.

ELZONRIS contains sorbitol (E420) and sodium Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.

You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially sodium-free .

ELZONRIS will be given to you in a hospital or clinic under the supervision of a doctor.

About an hour before your treatment begins, you will be given medicines to help prevent an allergic reaction, including anti-histamines, a corticosteroid and paracetamol.

The amount of ELZONRIS given to you is based on your body weight and will be calculated by your doctor. The daily recommended dose is 12 micrograms per kilogram of your body weight. It is given as a 15-minute drip into a vein (intravenous infusion), once a day, for the first 5 days of a 21-day cycle.

The first cycle will be given to you in hospital. You will be monitored for any side effectsduring treatment and for at least 24 hours after the last dose.

You will usually have more than one cycle of treatment. Your doctor will decide how many treatments you will receive.

If the first cycle does not cause troublesome side effects, your next cycle of treatment may be given in a clinic. You will be monitored during treatment.

If you miss a dose of ELZONRIS
It is very important for you to keep all your appointments to receive ELZONRIS. If you miss an appointment, ask your doctor when to schedule your next dose.

If you stop using ELZONRIS
Do not stop treatment with ELZONRIS without first talking to your doctor. Stopping your treatment may make your condition worse.

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

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

Serious side effects: Tell your doctor immediately if you experience the following side effects, as you may need urgent medical attention:

• any one or combination of: weight gain, swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion. These could be symptoms of a condition called capillary leak syndrome which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

Other side effects: Tell your doctor if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people):

• Abnormal blood tests (decreased platelets [thrombocytopenia]; red blood cells [anaemia]; decreased albumin in the blood [hypoalbuminemia])

• Low blood pressure (hypotension)

• Feeling or being sick (nausea; vomiting)

• Fever (pyrexia)

• Chills

• Tiredness (fatigue)

• Swelling of limbs and/or joints (peripheral oedema)

• Abnormal liver function tests (increased aspartate aminotransferase; increased alanine aminotransferase)

• Weight gain

Common (may affect up to 1 in 10 people):

• Skin infection (cellulitis)
• Decreased white blood cells with/without a fever (neutropenia, leukopenia, lymphopenia; febrile neutropenia)
• Complications from breakdown of cancer cells (tumour lysis syndrome)
• Reaction to treatment [including fever, feeling sick, headache, rash, rapid heartbeat] (cytokine release syndrome)
• Abnormal blood tests [Increased white blood cells (leukocytosis), increased uric acid in the blood (hyperuricaemia); decreased calcium in the blood (hypocalcaemia); decreased magnesium in the blood (hypomagnesaemia); decreased sodium in the blood (hyponatraemia); decreased potassium in the blood (hypokalaemia), increased blood potassium (hyperkalaemia), increased blood phosphate (hyperphosphataemia), increased bile pigment in the blood (hyperbilirubinemia), increased level of blood sugar (hyperglycaemia), incresed time for blood to clot (activated partial thromboplastin time prolonged, international normalised ratio increased)]
• Decreased appetite
• Feeling confused
• Fainting (syncope)
• Headache
• Dizziness
• Blurred vision
• Fluid around the heart (percardial effusion)
• Abnormal or fast heartbeat (tachycardia, sinus tachycardia)
• Blushing (flushing)
• Decreased level of oxygen in the body (hypoxia)
• Fluid in the lungs (pulmonary oedema)
• Build-up of fluid around the lungs that may cause breathlessness (pleural effusion)
• Difficulty breathing (dyspnoea)
• Nose bleeds (epistaxis)
• Coughing
• Difficulty swallowing (dysphagia)
• Diarrhoea
• Constipation
• Dry mouth or a swollen and sore mouth (stomatitis)
• Indigestion (dyspepsia)
• Itchy skin (pruritis)
• Skin rashes
• Excessive sweating (hyperhydrosis)
• Very small purple, red, or brown spots on the skin (petechiae)
• Pain in shoulders, neck, wrists, legs, and/or arms (pain in extremity), chest, back, joints (arthralgia), muscles (myalgia) or bones.
• Muscle weakness
• Kidneys suddenly stop working (acute kidney injury) and/or abnormal kidney function tests (increased blood creatinine)
• Flu-like symptoms such as aches and pains, fever and shaking
• Chest pain
• Generally feeling unwell (malaise)
• Abnormal heart rhythm (Electrocardiogram QT prolonged)
• Increased levels of enzymes in the blood seen in blood tests (lactate dehydrogenase, alkaline phosphatase and creatine phosphokinase)
• Flushing, shivering, fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing during the infusion or after the infusion on the first day of treatment (infusion-related reaction)
• Bruising (contusions)

Uncommon: may affect up to 1 in 100 people:

• Lung infection (pneumonia)
• Urinary tract infection
• Gum disease (gingivitis) including bleeding gums
• Blood test abnormalities [decreased phosphate in the blood (hypophosphataemia), increased lactic acid in the bloodstream (lactic acidosis/acidosis), decreased levels of a blood clotting protein (blood fibrinogen decreased)]
• Unusual mood changes including depression and anxiety
• Trouble sleeping (insomnia)
• Brain function disturbances (encephalopathy/ metabolic encephalopathy)
• Stroke
• Loss of movement in face (facial paralysis)
• Persistent bad taste in mouth (dysgeusia)
• Worsening of multiple sclerosis (relapse)
• Drowsiness (somnolence)
• Tingling or numbness (paraesthesia, peripheral sensory neuropathy)
• Weakness in muscles (peripheral motor neuropathy)
• Bleeding in the white of the eye (conjunctival haemorrhage)
• Eye redness (ocular hyperaemia)
• Eye floaters (vitreous floaters)
• Irregular heartbeat which can lead to the heart stopping (supraventricular extrasystoles, ventricular fibrillation, atrial fibrillation)
• Slow heart rate (bradycardia)
• Heart attack (myocardial infarction)
• High blood pressure (hypertension)
• Lungs do not function as they should, causing breathlessness (respiratory failure)
• Noisy breathing (wheezing)
• Mouth and/or throat pain (oropharyngeal pain)
• Rapid breathing (tachypnoea)
• Bloated stomach and stomach ache
• Blisters on the tongue
• Blood blister on tongue (tongue haematoma)
• Swelling of the face, tongue, limbs or joints (angioedema)
• Redness, swelling and pain on the palms of the hands and/or the soles of the feet (palmar-plantar erythrodysesthesia syndrome)
• Hives (urticaria)
• Hair loss (alopecia)
• Skin pain
• Dry, red, itchy skin and/or sores on the lower legs (stasis dermatitis)
• Cold sweat
• Dry skin
• Pain of joints, muscles and/or bones, including tail bone (musculoskeletal pain, coccydynia)
• Muscle spasm
• Muscle pain, weakness, dark or brown urine (rhabdomyolysis)
• Kidney failure
• Difficulty passing urine
• Pain in lower back/ abdomen and/or painful urination (urinary tract pain)
• Frequent daytime urination (pollakiuria)
• Urine test abnormality [increased protein (proteinuria)]
• Inability to tolerate side effects of this medicine (drug intolerance)
• Low body temperature (hypothermia)
• Fever or low body temperature, increased heart rate, increased breathing (systemic inflammatory response syndrome)
• Increase in time taken for blood to clot (shown in blood tests)
• Test positive for bacteria
• Decreased weight

Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

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

Unopened vial: Store and transport frozen (-20 C 5 C)

Keep the vial in the outer carton in order to protect from light.

Diluted solution: use immediately or store below 25 C and use within 4 hours. Do not re-freeze, once thawed.

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away medicines you no longer use. These measures will help protect the environment.

What ELZONRIS contains

• The active substance is tagraxofusp. Each vial contains 1 mg of tagraxofusp in 1mL of concetrate.
• The other ingredients are trometamol, sodium chloride, sorbitol (E420) and water for injections (see section 2 ELZONRIS contains sorbitol (E420) and sodium ).

What ELZONRIS looks like and contents of the pack ELZONRIS concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid. A few white to translucent particles may be present.

The pack size is 1 glass vial per carton.

Marketing Authorisation Holder
Stemline Therapeutics B.V. Basisweg 10, 1043 AP Amsterdam Netherlands

Manufacturer Stemline Therapeutics B.V. Basisweg 10, 1043 AP Amsterdam
Netherlands

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:

Belgi /Belgique/Belgien; ; esk republika; Danmark; Eesti; ; Hrvatska; Ireland; sland; ; Latvija; Lietuva; Italia Menarini Stemline Italia S.r.l. Tel: +39 800776EUmedinfo@menarinistemline.com

Luxembourg/Luxemburg; Magyarorsz g; Malta; Nederland; Norge; Polska; Portugal; Rom nia; Slovenija; Slovensk republika; Suomi/Finland; Sverige Stemline Therapeutics B.V. Tel: +44 (0)800 047 8EUmedinfo@menarinistemline.com

Deutschland Menarini Stemline Deutschland GmbH Tel: +49 (0)800 0008EUmedinfo@menarinistemline.com

sterreich Stemline Therapeutics B.V. Tel: +43 (0)800 297 EUmedinfo@menarinistemline.com Espa a Menarini Stemline Espa a, S.L.U. Tel: +34919490EUmedinfo@menarinistemline.com

United Kingdom (Northern Ireland) Stemline Therapeutics B.V. Tel: +44 (0)800 047 8EUmedinfo@menarinistemline.com

France Stemline Therapeutics B.V. T l: +33 (0)800 991EUmedinfo@menarinistemline.com

This leaflet was last revised in

This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: