Bugvi 5 mg/ml powder for dispersion for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bugvi 5 mg/ml powder for concentrate for solution for infusion EFG

paclitaxel

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Bugvi is and what it is used for

2. What you need to know before using Bugvi

3. How to use Bugvi

4. Possible side effects

5. How to store Bugvi

6. Contents of the container and other information

1. What Bugvi is and what it is used for

What Bugvi is

Bugvi contains, as its active substance, paclitaxel bound to human albumin protein, in the form of tiny particles called nanoparticles. Paclitaxel belongs to a group of medicines known as "taxanes" used in cancer treatment.

• Paclitaxel is the part of the medicine that acts on cancer; it works by preventing cancer cells from dividing, which causes them to die.
• Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and cross blood vessel walls to reach the tumor. This means it is not necessary to use other chemical agents that may cause adverse reactions which could be life-threatening. Such adverse reactions occur much less frequently with this medicine.

What Bugvi is used for

This medicine is used to treat the following types of cancer:

Breast cancer

• Breast cancer that has spread to other parts of the body (this is called "metastatic" breast cancer).
• This medicine is used in metastatic breast cancer when at least one other therapy has been tried but has not worked, and when your condition is not suitable for treatment with a group of medicines called "anthracyclines".
• People with metastatic breast cancer who received this medicine after another treatment had failed had a higher chance of experiencing tumor shrinkage and lived longer than those who received an alternative treatment.

Pancreatic cancer

• This medicine is used in combination with a medicine called gemcitabine if you have metastatic pancreatic cancer. In a clinical trial, people with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received paclitaxel with gemcitabine lived longer than those who received gemcitabine alone.

Lung cancer

• This medicine is also used in combination with a medicine called carboplatin if you have the most common type of lung cancer, called "non-small cell lung cancer".
• This medicine is used in non-small cell lung cancer when surgery or radiotherapy are not suitable for treating the disease.

2. What you need to know before using Bugvi

DO NOT use Bugvi

• if you are allergic (hypersensitive) to paclitaxel or to any of the other components of this medicine (listed in section 6)
• if you are breastfeeding
• if you have a low white blood cell count (neutrophil count <1,500 cells/mm³ before starting treatment. Your doctor will advise you on this)

Warnings and precautions

Talk to your doctor or nurse before starting to use this medicine

• if you have reduced kidney function
• if you have severe liver problems
• if you have heart conditions

If you experience any of the following conditions while receiving treatment with this medicine, inform your doctor or nurse. Your doctor may decide to interrupt the treatment or reduce the dose:

• if you experience unusual bruising, bleeding, or signs of infection such as sore throat or fever
• if you experience numbness, tingling, prickling sensations, sensitivity to touch, or muscle weakness
• if you experience breathing problems, such as difficulty breathing or dry cough

Children and adolescents

This medicine is intended for adults only and must not be given to children or adolescents under 18 years of age.

Other medicines and Bugvi

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal medicines. This is because this medicine may affect how some medicines work. Likewise, some medicines may affect how this medicine works.

Be cautious and consult your doctor when using this medicine together with any of the following:

• medicines used to treat infections (i.e., antibiotics such as erythromycin, rifampicin, etc.; if you are unsure whether the medicine you are taking is an antibiotic, ask your doctor, nurse, or pharmacist), and medicines used to treat fungal infections (e.g., ketoconazole)
• medicines used to help stabilize mood, also known as antidepressants (e.g., fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g., carbamazepine, phenytoin)
• medicines used to help lower blood lipid levels (e.g., gemfibrozil)
• medicines used for stomach acidity or stomach ulcers (e.g., cimetidine)
• medicines used to treat HIV and AIDS (e.g., ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• the medicine called clopidogrel, which is used to prevent blood clots.

Pregnancy, breastfeeding and fertility

Paclitaxel may cause severe birth defects and therefore must not be used during pregnancy. Your doctor will request a pregnancy test before starting treatment with this medicine.

Women of childbearing potential must use effective contraception during treatment and for one month after completion of treatment.

This medicine must not be used during breastfeeding, as it is unknown whether the active substance paclitaxel passes into breast milk.

Men being treated with this medicine are advised to use effective contraception and avoid fathering a child during treatment and for six months after treatment ends. They should also seek information about the possibility of sperm preservation before starting treatment, due to the risk of irreversible infertility caused by treatment with this medicine.

Consult your doctor before using this medicine.

Driving and using machines

Some people may feel tired or dizzy after receiving this medicine. If this happens to you, do not drive or operate any tools or machinery.

If you are taking other medicines as part of your treatment, consult your doctor regarding your ability to drive and use machines.

Bugvi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml of ready-to-administer solution; therefore, it is essentially “sodium-free”.

3. How to use Bugvi

A doctor or nurse will administer this medicine into a vein through an intravenous infusion system. The dose you receive is calculated based on your body surface area and blood test results.

The usual dose for breast cancer is 260 mg/m² of body surface area, administered over 30 minutes.

The usual dose for advanced pancreatic cancer is 125 mg/m² of body surface area, administered over 30 minutes.

The usual dose for non-small cell lung cancer is 100 mg/m² of body surface area, administered over 30 minutes.

How often will Bugvi be administered?

For the treatment of metastatic breast cancer, this medicine is usually given once every three weeks (day 1 of a 21-day cycle).

For the treatment of metastatic pancreatic cancer, this medicine is given on days 1, 8, and 15 of each 28-day cycle, with gemcitabine administered immediately after this medicine.

For the treatment of non-small cell lung cancer, this medicine is given once a week (i.e., on days 1, 8, and 15 of a 21-day cycle), with carboplatin administered once every three weeks (i.e., only on day 1 of each 21-day cycle), immediately after administration of this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Very common adverse effects may affect more than 1 in 10 people:

• Hair loss (most cases of hair loss occurred within less than one month after starting paclitaxel treatment. When it occurs, hair loss is severe (more than 50%) in most patients)
• Skin rash
• Abnormally low levels of certain types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood
• Reduction in red blood cells
• Decreased number of platelets in the blood
• Effects on peripheral nerves (pain, numbness, tingling or loss of sensation)
• Pain in one or more joints
• Muscle pain
• Nausea, diarrhoea, constipation, mouth pain, loss of appetite
• Vomiting
• Weakness and tiredness, fever
• Dehydration, altered taste, weight loss
• Low blood potassium levels
• Depression, sleep problems
• Headache
• Chills
• Difficulty breathing
• Dizziness
• Swelling of mucous membranes and soft tissues
• Increased liver enzyme levels in liver function tests
• Pain in the limbs
• Cough
• Abdominal pain
• Nosebleed

Common adverse effects may affect up to 1 in 10 people:

• Itching, dry skin, nail disorders
• Infection, fever with low levels of a type of white blood cell (neutrophils) in the blood, flushing, mouth ulcers, severe blood infection due to reduced white blood cells
• Reduction in all blood cell counts
• Chest or throat pain
• Indigestion, abdominal discomfort
• Nasal congestion
• Back pain, bone pain
• Decreased muscle coordination or difficulty reading, increased or decreased tear production, eyelash loss
• Changes in heart rate or rhythm, heart failure
• Low or high blood pressure
• Redness or swelling at the injection site
• Anxiety
• Lung infection
• Urinary tract infection
• Intestinal obstruction, inflammation of the large intestine, inflammation of the bile duct
• Acute kidney failure
• Increased bilirubin in the blood
• Coughing up blood
• Dry mouth, difficulty swallowing
• Muscle weakness
• Blurred vision

Uncommon adverse effects may affect up to 1 in 100 people:

• Weight gain, increased blood lactate dehydrogenase, impaired kidney function, increased blood glucose, increased blood phosphorus
• Reduced or absent reflexes, involuntary movements, nerve pain, fainting, dizziness upon standing, tremors, facial nerve paralysis
• Irritated eyes, eye pain, red eyes, itchy eyes, double vision, reduced vision, flashing lights, blurred vision due to retinal inflammation (cystoid macular edema)
• Ear pain, ringing in the ears
• Cough with phlegm, shortness of breath when walking or climbing stairs, runny or dry nose, decreased breath sounds, fluid in the lung, loss of voice, blood clot in the lungs, dry throat
• Gas, stomach cramps, gum pain, rectal bleeding
• Pain when urinating (dysuria), need to urinate more often than usual (frequency), blood in urine, involuntary loss of urine (urinary incontinence)
• Nail pain, nail discomfort, nail loss, hives, skin pain, photosensitivity reaction, pigmentation disorders, increased sweating, night sweats, white spots on the skin, sores, facial swelling
• Low blood phosphorus, fluid retention, low blood albumin, increased thirst, low blood calcium, low blood sugar, low blood sodium
• Nasal swelling and pain, skin infections, catheter-related infection
• Bruising
• Pain at tumour site, tumour necrosis
• Drop in blood pressure upon standing, cold extremities
• Difficulty walking, swelling
• Allergic reaction
• Decreased liver function, enlarged liver
• Chest pain
• Restlessness
• Small skin bleeds due to blood clots
• A condition involving destruction of red blood cells and acute kidney failure

Rare adverse effects may affect up to 1 in 1,000 people:

• Skin reaction to another agent or lung inflammation following radiation
• Blood clots
• Very slow pulse, heart attack
• Leakage of medicine from the vein (extravasation)
• Heart conduction disorder (atrioventricular block)

Very rare adverse effects may affect up to 1 in 10,000 people:

• Severe skin and mucous membrane inflammation/rash (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data):

• Hardening/thickening of the skin (scleroderma)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bugvi

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

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

Unopened vials: Store the vial in the outer packaging to protect it from light.

After the first reconstitution, the dispersion should be used immediately. If not used immediately, the vial containing the dispersion must be stored inside its outer packaging to protect it from light and kept refrigerated (2 °C–8 °C) for up to 24 hours.

The reconstituted dispersion in the infusion bag may be stored refrigerated (2 °C–8 °C), protected from light, for up to 24 hours.

The total combined storage time of the reconstituted medicine in the vial and in the infusion bag, when refrigerated and protected from light, is 24 hours. After this, it may be kept in the infusion bag for up to 4 hours at temperatures below 25 °C.

Your doctor or pharmacist is responsible for the proper disposal of any unused medicine.

6. Contents of the pack and other information

Composition of Bugvi

The active substance is paclitaxel.

Each vial contains 100 mg of paclitaxel bound to albumin in a nanoparticle formulation.

After reconstitution, each ml of dispersion contains 5 mg of paclitaxel bound to albumin in a nanoparticle formulation.

The other component is human albumin (containing sodium caprylate and N-acetyl L-tryptophan).

Appearance of the product and contents of the pack

Bugvi is a powder for dispersion for infusion, white to yellow in colour.

Bugvi is available in glass vials containing 100 mg of paclitaxel bound to albumin in a nanoparticle formulation.

Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Date of the most recent revision of this summary: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

For physicians or healthcare professionals

This information is intended solely for physicians or healthcare professionals:

Instructions for use, preparation and disposal

Preparation and administration precautions

Paclitaxel is a cytotoxic antineoplastic medicinal product; therefore, this medicinal product must be handled with care, as with other potentially toxic drugs. Gloves, safety goggles and protective clothing must be used. In case of skin contact, the affected area must be washed immediately and thoroughly with water and soap. In case of contact with mucous membranes, they must be thoroughly rinsed with copious amounts of water. This medicinal product must only be prepared and administered by personnel experienced in handling cytotoxic agents. Pregnant women should not handle this medicinal product.

Due to the possibility of extravasation, close monitoring of the infusion site is recommended to detect any occurrence during administration of the medicinal product. Limiting the infusion time of this medicinal product to 30 minutes, as per instructions, reduces the likelihood of infusion-related reactions.

Reconstitution and administration of the medicinal product

This medicinal product must be administered under the supervision of a qualified oncologist in specialized units for the administration of cytotoxic agents.

This medicinal product is supplied as a sterile lyophilized powder for reconstitution prior to use. After reconstitution, each ml of dispersion contains 5 mg of paclitaxel bound to albumin in a nanoparticle formulation. The reconstituted dispersion of this medicinal product is administered intravenously using an infusion set incorporating a 15 µm filter.

Reconstitution of 100 mg

Using a sterile syringe, slowly inject 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion into the vial of 100 mg of this medicinal product over a minimum of 1 minute.

The solution should be directed onto the inner wall of the vial. The solution must not be injected directly onto the powder, as this may cause foaming.

After adding the solution, allow the vial to stand for at least 5 minutes to ensure proper wetting of the solute. Then gently and carefully shake and/or slowly invert the vial for at least 2 minutes until complete redispersion of the powder is achieved. Foaming should be avoided. If foam or lumps form, allow the dispersion to stand for at least 15 minutes until the foam disappears.

The reconstituted dispersion should appear milky and homogeneous without visible precipitates. Some sedimentation of the reconstituted dispersion may occur. If precipitate or sedimentation is observed, gently invert the vial again to achieve complete redispersion before use.

Inspect the dispersion in the vial for particles. Do not administer the reconstituted dispersion if particles are observed in the vial.

The exact total volume of 5 mg/ml dispersion required for the patient should be calculated, and the appropriate amount of this reconstituted medicinal product should be injected into an empty, sterile intravenous infusion bag, either PVC or non-PVC.

The use of medical devices containing silicone oil as lubricant (e.g., syringes and IV bags) for reconstituting and administering this medicinal product may lead to the formation of protein filaments. This medicinal product must be administered using an infusion set incorporating a 15 µm filter to prevent administration of these filaments. The use of a 15 µm filter removes the filaments and does not alter the physical or chemical properties of the reconstituted medicinal product.

The use of filters with a pore size smaller than 15 µm may result in filter blockage.

There is no need for DEHP-free containers or administration sets for the preparation or administration of infusions of this medicinal product.

After administration, it is recommended to thoroughly flush the intravenous line with 9 mg/ml (0.9%) sodium chloride injection solution to ensure complete delivery of the dose.

Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.

Stability

Unopened vials of this medicinal product remain stable until the date indicated on the packaging if stored in the outer carton to protect from light. Freezing or refrigeration does not adversely affect the stability of the medicinal product. This medicinal product does not require any special storage temperature.

Stability of the reconstituted dispersion in the vial

Chemical and physical stability has been demonstrated for 24 hours at 2 °C–8 °C in the original container, protected from light.

Stability of the reconstituted dispersion in the infusion bag

Chemical and physical stability has been demonstrated for 24 hours at 2 °C–8 °C followed by 4 hours at 25 °C, protected from light.

However, from a microbiological standpoint, unless the reconstitution and filling process of the infusion bags eliminates the risk of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.

If not used immediately, the storage times and conditions of the product in use are the responsibility of the user.

The total combined storage time of the reconstituted medicinal product in the vial and in the infusion bag, when refrigerated and protected from light, is 24 hours. This may then be followed by storage in the infusion bag for 4 hours at a temperature below 25 °C.