Leaflet: information for the user

Bugvi 5mg/ml powder for dispersion for EFG infusion

paclitaxel

Read this 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, consult your doctor or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

What is Bugvi

Bugvi contains, as the active ingredient, paclitaxel bound to human albumin, in the form of tiny particles called nanoparticles. Paclitaxel belongs to a group of medications called “taxanes” that are used in cancer treatment.

• Paclitaxel is the part of the medication that affects cancer; it acts by preventing cancer cells from dividing, which means they die.
• Albumin is the part of the medication that helps paclitaxel dissolve in the blood and cross blood vessel walls to reach the tumor. This means thatno other chemical agentsare needed that can produce adverse effects that can be life-threatening. These adverse effects occur much less frequently with this medication.

How is Bugvi used

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

Breast cancer

• Metastatic breast cancer (cancer that has spread to other parts of the body).
• This medicationis used in metastatic breast cancer when at least one other therapy has been tried but was not effective and the case is not suitable for treatment with a group of medications called “anthracyclines”.
• People with metastatic breast cancer who receivedthis medicationwhen another treatment had failed, had a greater chance of experiencing a reduction in tumor size, and lived longer than people who received an alternative treatment.

Pancreatic cancer

• This medicationis used in combination with a medication called gemcitabine if you have metastatic pancreatic cancer (cancer that has spread to other parts of the body). People with metastatic pancreatic cancer (cancer that has spread to other parts of the body) who received paclitaxel with gemcitabine in a clinical trial lived longer than people who only received gemcitabine.

Lung cancer

• This medicationis also used in combination with a medication called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
• This medicationis used in non-small cell lung cancer when surgery or radiation therapy is not suitable for treating the disease.

Do not use Bugvi

• If you are allergic (hypersensitive) to paclitaxel or any of the other components of this medication(listed in section 6)
• If you are breastfeeding
• If you have a low white blood cell count (neutrophil count <1,500 cells/mm3before starting treatment. Your doctor will advise you on this)

Warnings and precautions

Consult your doctor or nurse before starting to usethis medication

• If you have reduced kidney function
• If you have severe liver disease
• If you have heart disease

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

• If you experience any abnormal bruising, bleeding, or signs of infection such as sore throat or fever
• If you experience numbness, tingling, pins and needles, sensitivity to touch, or muscle weakness
• If you experience respiratory problems, such as difficulty breathingor dry cough

Children and adolescents

This medication is only indicated for adults and should not be administered to children or adolescents under 18years.

Other medications and Bugvi

Inform your doctor if you are using or have recently used any other medication, including those purchased without a prescription, including herbal medications. This is because this medicationmay affect the way some medications work. Similarly, some medications may affect the waythis medication works.

Be careful and consult your doctor when usingthis medicationat the same time as any of the following:

• Medications to treat infections (e.g., antibiotics such as erythromycin, rifampicin, etc.; in case of doubt about whether the medication you are taking is an antibiotic, ask your doctor, nurse, or pharmacist), and medications to treat fungal infections (e.g., ketoconazole)
• Medications used to help stabilize mood, also known as antidepressants (e.g., fluoxetine)
• Medications used to treat seizures (epilepsy) (e.g., carbamazepine, phenytoin)
• Medications used to help reduce blood lipid levels (e.g., gemfibrozil)
• Medications used to treat stomach acid or stomach ulcers (e.g., cimetidine)
• Medications used to treat HIV and AIDS (e.g., ritonavir, saquinavir, indinavir, nelfinavir, efavirenz,nevirapina)
• The medicationcalledclopidogrel, which is used to prevent blood clots.

Pregnancy, breastfeeding, and fertility

Paclitaxel may cause severe congenital defects, so it should not be used if you are pregnant. Your doctor will request a pregnancy test before starting treatment with this medication.

Women of childbearing age should use effective contraceptive methods during and for one month after completing treatment with this medication.

This medicationshould not be used during breastfeeding as it is unknown whether the active ingredient paclitaxel passes into breast milk.

Men treated with this medication are advised to use effective contraceptive methods and avoid fathering children during treatment and for six months after completing it, as well as to inform themselves about the possibility of preserving their sperm before starting treatment, given the possibility of irreversible infertility.

Consult your doctor beforeusingthis medication.

Driving and operating machinery

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

If you are taking other medications as part of your treatment, consult your doctor about your abilityto drive and usemachinery.

Bugvi contains sodium

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

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

Theusual dose for breast canceris 260mg/m2of body surface area, administered over 30minutes.

Theusual dose for advanced pancreatic canceris 125mg/m2of body surface area, administered over 30minutes.

Theusual dose for non-small cell lung canceris100mg/m2of body surface area, administered over 30minutes.

How often will Bugvi be administered to you?

Formetastatic breast cancer treatment, this medication is usually administered once every three weeks (on day 1 of a 21day cycle).

Formetastatic pancreatic cancer treatment, this medication is administered on days 1, 8, and 15 of each 28day cycle, with gemcitabina administered immediately after this medication.

Fornon-small cell lung cancer treatment, this medication is administeredonce a week (i.e., on days1, 8, and 15 of a 21day cycle), withcarboplatino administered once every three weeks (i.e., only on day1 of each 21day cycle),immediately after administering the dose ofthis medication.

If you have any other questions about using this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effectsvery commonmay affect more than 1 in 10people

• hair loss (most cases of hair loss occurred within less than a month after starting treatment with paclitaxel. When it occurs, hair loss is severe (more than 50%) in most patients)
• skin rash
• abnormal decrease in the number of some types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood
• decrease in red blood cells
• decrease in the number of platelets in the blood
• effect on peripheral nerves (pain, numbness, tinglingor loss of sensation)
• joint pain in one or more joints
• muscle pain
• nausea, diarrhea, constipation, mouth pain, loss of appetite
• vomiting
• weakness and fatigue, fever
• dehydration, alteration of taste, weight loss
• low potassium levels in the blood
• depression, sleep problems
• headache
• chills
• difficulty breathing
• dizziness
• swelling of the mucous membranes and soft tissues
• increase in liver values in liver function tests
• pain in the extremities
• cough
• abdominal pain
• nasal bleeding

Side effectscommonmay affect up to 1 in 10people

• itching, dry skin, nail problems

• infection, fever with a decrease in the number of a type of white blood cell (neutrophils) in the blood, redness, mouth ulcers, severe blood infection that may be due to a decrease in white blood cells
• decrease in all blood cell values
• chest or throat pain
• indigestion, abdominal discomfort
• nasal congestion
• back or bone pain
• decrease in muscle coordination or difficulty reading, increased or decreased tearing, 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
• increase in bilirubinin the blood
• coughing up blood
• dry mouth, difficulty swallowing
• muscle weakness
• blurred vision

Side effectsuncommonmay affect up to 1 in 100people

• weight gain, increase in lactate dehydrogenase in the blood, alterationof renal function, increase in blood glucose, increase in blood phosphorus
• decrease or absence of reflexes, involuntary movements, nerve pain, fainting, dizziness when standing, tremors, facial nerve paralysis
• irritated eyes, eye pain, red eyes, itching in the eyes, double vision, reduced vision, or flashing lights, blurred vision due to inflammation of the retina (macular cystoid edema)
• ear pain, ringing in the ears
• coughing up mucus, shortness of breath when walking or climbing stairs, dry nose, decreased respiratory sounds, fluid in the lung, loss of voice, blood clot in the lungs, dry throat
• gas, stomach cramps, tooth pain, rectal bleeding
• painful urination (dysuria), frequent urination, blood in the urine, involuntary loss of urine (urinary incontinence)
• finger or toenail pain, nail problems, loss of nails, hives, skin pain, photosensitivity reaction, skin pigmentation disorders, increased sweating, night sweats, white patches on the skin, sores, facial swelling
• decrease in phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decrease in calcium in the blood, decrease in blood sugar, decrease in sodium in the blood
• nose pain, skin infections, catheter-related infection
• bruising
• tumor pain, tumor necrosis
• decrease in blood pressure when standing, cold extremities
• difficulty walking, swelling
• allergic reaction
• decrease in liver function, enlargement of the liver
• chest pain
• nervousness
• small skin bleeding due to blood clots
• a condition that involves the destruction of red blood cells and acute kidney failure

Side effectsraremay affect up to 1 in 1,000people

• skin reaction to another agent or pulmonary inflammation after radiation
• blood clots
• slow pulse, heart attack
• medication leakage outside the vein
• conduction disorder of the heart's electrical system (atrioventricular block)

Side effectsvery raremay affect up to 1 in 10,000people

• severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Frequencynot known(cannot be estimated from available data)

• hardening/thickening of the skin (scleroderma).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the vial after CAD. The expiration date is 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 must be used immediately. If not used immediately, the vial with the dispersion must be stored within its outer packaging to protect it from light in the refrigerator (2 °C-8 °C) for a maximum of 24 hours.

The reconstituted dispersion in the infusion bag can be stored in the refrigerator (2 °C-8 °C) for a maximum of 24 hours protected from light.

The total storage time combining the reconstituted medication in the vial and in the infusion bag when refrigerated and protected from light is 24 hours. It can then be stored in the infusion bag for 4 hours below 25 °C.

Your doctor or pharmacist is responsible for properly disposing of any unused remainder of this medication.

Composition of Bugvi

The active principle 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 (contains sodium caprylate and N-acetyl L-tryptophan).

Appearance of the product and contents of the package

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

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

Each package contains 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Last review date of this leaflet:April 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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Doctors or healthcare professionals

This information is intended solely for doctors or healthcare professionals:

Instructions for use, preparation, and disposal

Precautions for preparation and administration

Paclitaxel is a cytotoxic anticancer drug, so this medication must be handled with caution, as with other potentially toxic drugs. Gloves, safety glasses, and protective clothing should be used. In case of skin contact, the affected area should be washed immediately and thoroughly with water and soap. In case of contact with mucous membranes, they should be washed thoroughly with plenty of water. This medication should only be prepared and administered by experienced personnel in the handling of cytotoxic agents. Pregnant women should not handle this medication.

Due to the possibility of extravasation, it is recommended to closely monitor the infusion site for any signs of extravasation during administration of the medication. Limiting the infusion time of this medication to 30 minutes, as instructed, reduces the likelihood of reactions associated with infusion.

Reconstitution and administration of the medication

This medication should be administered under the supervision of a qualified oncologist in specialized units for the administration of cytotoxic agents.

This medication is presented as a sterile lyophilized powder for reconstitution before use. After reconstitution, each ml of dispersion contains 5 mg of paclitaxel bound to albumin in a nanoparticle formulation. The dispersion of this reconstituted medication is administered intravenously using a perfusion equipment that includes a 15 µm filter.

Reconstitution of 100 mg

Using a sterile syringe, slowly inject 20 ml of 0.9% sodium chloride solution for infusion into the vial containing 100 mg of this medication over a minimum of 1 minute.

The solution should be directed directly towards the inner wall of the vial. The solution should not be injected directly into the powder, as this would produce foam.

After adding the solution, leave the vial to rest for a minimum of 5 minutes to ensure proper humidification of the solute. Then, gently and carefully agitate the vial or invert it slowly for at least 2 minutes until the powder is completely redispersed. Foam formation should be avoided. If foam or lumps form, leave the dispersion to rest for at least 15 minutes until the foam disappears.

The reconstituted dispersion should have a milky and homogeneous appearance without visible precipitates. Some sedimentation of the reconstituted dispersion may occur. If there are signs of precipitation or sedimentation, gently invert the vial to achieve complete redispersion before use.

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

The exact total volume of the 5 mg/ml dispersion needed for the patient should be calculated, and the appropriate amount of this reconstituted medication should be injected into a sterile, empty, and type PVC or non-PVC intravenous infusion bag.

The use of medical devices containing silicone oil as a lubricant (e.g., syringes and IV administration bags) for reconstituting and administering this medication may lead to the formation of protein filaments.This medication should be administered using a perfusion equipment that includes a 15 µm filter to prevent the administration of these filaments. The use of a 15 µm filter eliminates the filaments without altering the physical or chemical properties of the reconstituted medication.

The use of filters with a pore size less than 15 µm may lead to filter blockage.

No special containers or equipment without DEHP are required for preparing or administering perfusions of this medication.

After administration, it is recommended to thoroughly wash the intravenous route with 0.9% sodium chloride solution to ensure complete administration of the dose.

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.

Stability

Unopened vials of this medication remain stable until the date indicated on the packaging if stored in the outer packaging to protect them from light. Freezing or refrigeration do not negatively affect the stability of the medication. This medication 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 2-8°C in the original packaging, protected from light.

Stability of the reconstituted dispersion in the infusion bag

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

However, from a microbiological point of view, unless the reconstitution and filling method 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 storage time combining the reconstituted medication in the vial and in the infusion bag when refrigerated and protected from light is 24 hours. It can then be stored in the infusion bag for 4 hours at a temperature below 25°C.