Paclitaxel albumin Dr. Reddy's 5 mg/ml powder for dispersion for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paclitaxel Albumin Dr. Reddys 5 mg/ml powder for dispersion for infusion EFG

paclitaxel

Read the entire leaflet carefully before you start using this medicine, as 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; do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Paclitaxel Albumina Dr. Reddys is and what it is used for
2. What you need to know before starting to use Paclitaxel Albumina Dr. Reddys
3. How to use Paclitaxel Albumina Dr. Reddys
4. Possible side effects
5. Storage of Paclitaxel Albumina Dr. Reddys
6. Contents of the pack and other information

1. What Paclitaxel Albumin Dr. Reddy's is and what it is used for

Paclitaxel Albumin Dr. Reddy's is a medicine containing the active substance paclitaxel, bound to albumin (a human protein). Paclitaxel belongs to a group of medicines called taxanes, which are used in the treatment of cancer.

This medicine is used for the treatment of:

• Metastatic breast cancer (breast cancer that has spread to other parts of the body), in patients who have failed prior therapy for metastatic disease. Treatment with this medicine may be considered appropriate for patients who are not candidates for high-dose chemotherapy with hematopoietic stem cell support.
• Locally advanced or metastatic adenocarcinoma of the pancreas (cancer of the pancreas), in combination with gemcitabine, as a first-line treatment in patients who are not candidates for surgery.

Paclitaxel Albumin Dr. Reddy's works by interfering with the normal function of the cellular structures called microtubules, which are essential for cell division. By disrupting microtubule dynamics, paclitaxel prevents cancer cells from dividing and multiplying, ultimately leading to cancer cell death.

What is Paclitaxel Albumina Dr. Reddys

Paclitaxel Albumina Dr. Reddys contains, as the 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 affects cancer, acting by preventing cancer cells from dividing, which means they die.
• Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and cross the walls of blood vessels to reach the tumor. This means it is not necessary to use other chemical agents that may cause adverse reactions which can be life-threatening. Such adverse reactions occur much less frequently with Paclitaxel Albumina.

What Paclitaxel Albumin Dr. Reddy's 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).
• Paclitaxel Albumin Dr. Reddy's is used in metastatic breast cancer when at least one other therapy has already been tried but was ineffective, and your condition is not suitable for treatment with a group of medicines called "anthracyclines".
• Patients with metastatic breast cancer who received paclitaxel after failure of another treatment showed a higher likelihood of tumor shrinkage and lived longer than patients who received an alternative treatment.

Pancreatic cancer

• Paclitaxel Albumin is used in combination with a medicine called gemcitabine if you have metastatic pancreatic cancer. In a clinical trial, patients 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

• Paclitaxel Albumin Dr. Reddy's 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".
• Paclitaxel Albumin Dr. Reddy's 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 Paclitaxel Albumina Dr. Reddys

Do not use Paclitaxel Albumina Dr. Reddys

• if you are allergic (hypersensitive) to paclitaxel or to any of the other components of Paclitaxel Albumina Dr. Reddys (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

Consult your doctor or nurse before starting treatment with Paclitaxel Albumina

• if you have reduced kidney function;
• if you suffer from severe liver disorders;
• if you suffer from heart conditions.

If you experience any of these disorders while receiving treatment with Paclitaxel Albumina, 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

Paclitaxel Albumin is indicated only for adults and should not be administered to children or adolescents under 18 years of age.

Other medicines and Paclitaxel Albumin Dr. Reddy's

Inform your doctor if you are using or have recently used any other medicines, including those obtained without a prescription, such as herbal medicines. This is because Paclitaxel Albumin may affect how some medicines work. Likewise, some medicines may affect how this medicine works.

Be cautious and consult your doctor when using Paclitaxel Albumin together with any of the following:

• medicines used to treat infections (i.e., antibiotics such as erythromycin, rifampicin, etc.; if in doubt 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 called antidepressants (e.g.: fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g.: carbamazepine, phenytoin)
• medicines used to help reduce blood lipid levels (e.g.: gemfibrozil)
• medicines used for stomach acid 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 congenital defects and therefore must not be used if you are pregnant. Your doctor will require a pregnancy test before starting treatment with Paclitaxel Albumina.

Women of childbearing potential must use effective contraceptive methods during treatment and for at least six months after completion of treatment with Paclitaxel Albumina.

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

Men treated with Paclitaxel Albumina are advised to use effective contraception and avoid fathering a child during treatment and for at least three months after treatment ends. They should also seek information about the possibility of preserving sperm before starting treatment, given that treatment with Paclitaxel Albumina may cause irreversible infertility.

Consult your doctor before using this medicine.

Driving and using machines

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

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

Paclitaxel Albumin Dr. Reddy's contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 00 mg; essentially, "sodium-free".

3. How to use Paclitaxel Albumina Dr. Reddys

A doctor or nurse will administer Paclitaxel Albumina into your vein through an intravenous infusion system. Your dose 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 Paclitaxel Albumina Dr. Reddys be administered to you?

For the treatment of metastatic breast cancer, Paclitaxel Albumina is usually administered once every three weeks (day 1 of a 21-day cycle).

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

For the treatment of non-small cell lung cancer, Paclitaxel Albumina is administered 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 the Paclitaxel Albumina dose.

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 can cause adverse effects, although not everyone 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 treatment with paclitaxel albumin. 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
• Decreased red blood cells
• Low platelet count in the blood
• Effects on peripheral nerves (pain, numbness, tingling, or loss of sensation)
• Pain in one or more joints
• Muscle pain
• Nausea, diarrhea, constipation, mouth pain, loss of appetite
• Vomiting
• Weakness and fatigue, 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 values in liver function tests
• Pain in the limbs
• Cough
• Abdominal pain
• Nosebleeds

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 possibly 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 lungs, loss of voice, blood clot in the lungs, dry throat
• Gas, stomach cramps, gum pain, rectal bleeding
• Painful urination (dysuria), need to urinate more often than normal (frequent urination), 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 skin spots, sores, facial swelling
• Low blood phosphorus, fluid retention, low blood albumin, increased thirst, low blood calcium, low blood sugar, low blood sodium
• Pain and swelling in the nose, skin infections, catheter-related infection
• Bruising
• Pain at tumor site, tumor necrosis
• Drop in blood pressure upon standing, cold extremities
• Difficulty walking, swelling
• Allergic reaction
• Decreased liver function, enlarged liver
• Chest pain
• Nervousness
• 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 pulmonary inflammation following radiation
• Blood clots
• Very slow pulse, heart attack
• Leakage of medication 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Paclitaxel Albumina Dr. Reddys

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

This medicine does not require special storage temperature conditions.

After the first reconstitution, the dispersion should be used immediately. If not used immediately, the dispersion may be stored refrigerated (2°C-8°C) for up to 24 hours in the vial kept in the outer packaging to protect it from light.

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

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 a temperature below 25°C.

Your doctor or pharmacist is responsible for the proper disposal of any unused Paclitaxel Albumina Dr. Reddys.

6. Contents of the pack and other information

Composition of Paclitaxel Albumin Dr. Reddy's

• The active substance is paclitaxel.
• Each vial contains 100 mg paclitaxel bound to albumin in a nanoparticle formulation. After reconstitution, each ml of dispersion contains 5 mg paclitaxel bound to albumin in a nanoparticle formulation.
• The other component is human albumin solution (containing sodium caprylate and N-acetyl-L-tryptophan), see section 2 "Paclitaxel Albumin Dr. Reddy's contains sodium".

Appearance of the product and contents of the container

Paclitaxel Albumin Dr. Reddy's is a white to yellow powder for dispersion for perfusion.

Paclitaxel Albumin Dr. Reddy's is available in 50 ml clear glass vials, closed with a rubber stopper and flip-off seal, containing 100 mg of paclitaxel formulated as albumin-bound nanoparticles.

Each pack contains 1 vial.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

Betapharm Arzneimittel GmbH,

Kobelweg 95

86156 Augsburg

Germany

or

Rual Laboratories SRL,

313, Splaiul Unirii, Building H, 1st floor, sector 3

București, 030138

Romania

or

DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.

Str. Daniel Danielopolu, nr. 30-32, Spațiul 2, Etaj 5, Sectorul 1

București, 014134

Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State	Medicinal Product Name
Germany	Paclitaxel albumin beta 5 mg/ml Powder for the preparation of an infusion dispersion
Spain	Paclitaxel albumin Dr. Reddy's 5 mg/ml powder for infusion dispersion EFG
Italy	Paclitaxel albumin Dr. Reddy's 5 mg/ml powder for infusion dispersion
Sweden	Paclitaxel albumin Reddy 5 mg/ml powder for infusion dispersion
Romania	Paclitaxel albumin Dr. Reddy 5 mg/ml powder for infusion dispersion

Date of the last revision of this leaflet: July 2025

Detailed 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/.

Healthcare Professionals

This information is intended solely for healthcare professionals:

Instructions for Use, Preparation, and Disposal

Preparation and Administration Precautions

Paclitaxel is a cytotoxic antineoplastic agent; therefore, Paclitaxel Albumin must be handled with caution, as with other potentially toxic drugs. Gloves, safety goggles, and protective clothing should be worn. 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 abundant water. Paclitaxel Albumin must be prepared and administered only by personnel experienced in handling cytotoxic agents. Pregnant women must not handle Paclitaxel Albumin.

Due to the possibility of extravasation, the infusion site should be closely monitored for any signs of extravasation during administration. Limiting the infusion time of Paclitaxel Albumin to 30 minutes, as directed in the instructions, reduces the likelihood of infusion-related reactions.

Reconstitution and Administration of the Medicinal Product

Paclitaxel Albumin must be administered under the supervision of a qualified oncologist in specialized units for the administration of cytotoxic agents.

Paclitaxel Albumin is supplied as a sterile lyophilized powder for reconstitution prior to use. After reconstitution, each mL of the dispersion contains 5 mg of paclitaxel bound to albumin in a nanoparticle formulation. The reconstituted Paclitaxel Albumin dispersion 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 solution 9 mg/mL (0.9%) for infusion into the 100 mg vial of Paclitaxel Albumin over a period of at least 1 minute.

Reconstitution of 250 mg:

Using a sterile syringe, slowly inject 50 mL of sodium chloride solution 9 mg/mL (0.9%) for infusion into the 250 mg vial of Paclitaxel Albumin over a period of at least 1 minute.

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

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 clumps 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 precipitates or sedimentation are 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 the 5 mg/mL dispersion required for the patient should be calculated, and the appropriate amount of reconstituted Paclitaxel Albumin should be injected into an empty, sterile intravenous infusion bag made of PVC or non-PVC material.

The use of medical devices containing silicone oil as a lubricant (e.g., syringes and intravenous administration bags) for reconstituting and administering Paclitaxel Albumin may result in the formation of protein filaments. Paclitaxel Albumin should 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 lead to filter clogging.

There is no need to use DEHP-free solution containers or administration sets specifically for the preparation or administration of Paclitaxel Albumin infusions.

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

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

Stability

Unopened vials of Paclitaxel Albumina remain stable until the date indicated on the package when stored in the outer packaging to protect from light. Freezing or refrigeration does not negatively affect the stability of the medicinal product. This medicine 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 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 during 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. Subsequently, it may be stored in the infusion bag for up to 4 hours at a temperature below 25°C.