Paclitaxel albumin Dr. Reddy's

Package leaflet: Information for the user

Paclitaxel albumin Dr. Reddy’s 5 mg/mL powder for dispersion for infusion

paclitaxel
Generic medicine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

What this leaflet contains

1. What Paclitaxel albumin Dr. Reddy’s is and what it is used for
2. What you need to know before using Paclitaxel albumin Dr. Reddy’s
3. How to use Paclitaxel albumin Dr. Reddy’s
4. Possible side effects
5. How to store Paclitaxel albumin Dr. Reddy’s
6. Contents of the pack and other information

1. What is Paclitaxel albumin Dr. Reddy’s and what is it used for

What is Paclitaxel albumin Dr. Reddy’s
Paclitaxel albumin Dr. Reddy’s contains, as the active substance, paclitaxel bound to the human protein albumin, in the form of tiny particles known as nanoparticles. Paclitaxel belongs to a group of medicines called taxanes, which are used in cancer therapy.

• Paclitaxel is the part of the medicine that acts on the tumour by stopping tumour cells from dividing, thereby causing 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 tumour. This means that additional chemical substances, which may cause potentially life-threatening side effects, are not required. Such side effects are much less frequent with Paclitaxel albumin Dr. Reddy’s.

What Paclitaxel albumin Dr. Reddy’s is used for
Paclitaxel albumin Dr. Reddy’s is used to treat the following types of cancer:
Breast cancer

• Breast cancer that has spread to other parts of the body (called “metastatic” breast cancer).
• Paclitaxel albumin Dr. Reddy’s is used in metastatic breast cancer when at least one other therapy has been tried but was ineffective, and when the patient is not suitable for treatments containing a group of medicines called “anthracyclines”.
• Patients with metastatic breast cancer who received paclitaxel after a previous unsuccessful therapy were more likely to experience tumour shrinkage and lived longer compared to patients who received an alternative therapy.

Pancreatic cancer

• Paclitaxel is used in combination with a medicine called gemcitabine for metastatic pancreatic cancer. In a clinical study, patients with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) treated with paclitaxel and gemcitabine lived longer than those who received gemcitabine alone.

Lung cancer

• Paclitaxel is also used in combination with a medicine called carboplatin for the treatment of the most common type of lung cancer, known as “non-small cell lung cancer”.
• Paclitaxel is used in non-small cell lung cancer when surgery or radiotherapy are not suitable treatment options for the disease.

2. What you need to know before using Paclitaxel albumin Dr. Reddy’s

Do not use Paclitaxel albumin Dr. Reddy’s

• if you are allergic (hypersensitive) to paclitaxel or to any of the other ingredients of Paclitaxel albumin Dr. Reddy’s (listed in section 6);
• if you are breastfeeding;
• if you have a low white blood cell count (baseline neutrophil count < 1,500 cells/mm³ – your doctor will provide information on this).

Warnings and precautions
Talk to your doctor or nurse before using Paclitaxel albumin Dr. Reddy’s

• if you have reduced kidney function;
• if you have severe liver problems;
• if you have heart disorders.

Contact your doctor or nurse if you experience any of the following during treatment with Paclitaxel albumin Dr. Reddy’s; your doctor may decide to stop treatment or reduce the dose:

• unusual bruising, bleeding, or signs of infection such as sore throat or fever;
• numbness, tingling, prickling sensations, sensitivity to touch, or muscle weakness;
• breathing problems, such as shortness of breath or dry cough.

Children and adolescents
Paclitaxel albumin Dr. Reddy’s is intended for adults only and must not be used in children and adolescents under 18 years of age.
Other medicines and Paclitaxel albumin Dr. Reddy’s
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal supplements. This is because paclitaxel may affect the action of other medicines, and other medicines may affect the action of paclitaxel.
Be cautious and consult your doctor when taking paclitaxel together with any of the following:

• medicines used to treat infections (i.e. antibiotics, such as erythromycin, rifampicin, etc.; ask your doctor, nurse, or pharmacist for confirmation if you are unsure whether your medicine is an antibiotic), including medicines used to treat fungal infections (e.g. ketoconazole)
• medicines used to stabilize mood, sometimes also called antidepressants (e.g. fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
• medicines used to lower lipid levels in the blood (e.g. gemfibrozil)
• medicines used for heartburn or stomach ulcers (e.g. cimetidine)
• medicines used to treat HIV and AIDS (e.g. ritonavir,

saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)

• a medicine called clopidogrel used to prevent blood clots.

Pregnancy, breastfeeding and fertility
Paclitaxel may cause severe birth defects (at birth) and therefore must not be used during pregnancy. Your doctor will perform a pregnancy test before starting treatment with Paclitaxel albumin Dr. Reddy’s.
Women of childbearing potential must use effective contraception during treatment with paclitaxel and for at least 6 months after stopping treatment.
Do not breastfeed during treatment with Paclitaxel albumin Dr. Reddy’s, as it is not known whether the active substance paclitaxel passes into breast milk.
Male patients are advised to use effective contraception and to avoid fathering a child during treatment and for at least 3 months after stopping treatment. You should also discuss sperm preservation with your doctor before starting treatment, due to the possibility that paclitaxel therapy may cause permanent infertility.
Ask your doctor for advice before taking this medicine.
Driving and using machines
Some people may experience fatigue or dizziness after administration of paclitaxel. If this occurs, do not drive or operate tools or machinery.
If other medicines are prescribed 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 (23 mg) of sodium per 100 mg, i.e. essentially ‘sodium-free’.

3. How to use Paclitaxel albumina Dr. Reddy’s

Paclitaxel will be administered intravenously by infusion under the supervision of a doctor or nurse. The dose administered depends on 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 frequently is Paclitaxel albumina Dr. Reddy’s administered?
For the treatment of metastatic breast cancer, Paclitaxel albumina Dr. Reddy’s is usually given once every three weeks (on day 1 of a 21-day cycle).
For the treatment of advanced pancreatic cancer, Paclitaxel albumina Dr. Reddy’s is given on days 1, 8, and 15 of each 28-day treatment cycle, with gemcitabine administered immediately after paclitaxel.
For the treatment of non-small cell lung cancer, Paclitaxel albumina Dr. Reddy’s is given once a week (i.e., on days 1, 8, and 15 of a 21-day cycle), together with carboplatin, which is administered once every three weeks (i.e., only on day 1 of each 21-day cycle), immediately after the paclitaxel dose.

If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• Hair loss (most cases of hair loss occurred within less than one month from the start of paclitaxel treatment. When it occurs, hair loss is marked (over 50%) in most patients)
• Rash
• Abnormally low levels of certain types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood
• Deficiency of red blood cells (erythrocytes)
• Reduction in the 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 irritation, loss of appetite
• Vomiting
• Weakness and fatigue, fever
• Dehydration, altered taste, weight loss
• Low levels of potassium in the blood
• Depression, sleep disorders
• Headache
• Chills
• Difficulty breathing
• Dizziness
• Swelling of mucous membranes and soft tissues
• Increased liver function test values
• Pain in the extremities
• Cough
• Abdominal pain
• Nosebleed

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

• Itching, dry skin, nail changes
• Infection, fever with reduced number of a type of white blood cells (neutrophils) in the blood, hot flushes, candidiasis, severe blood infection that may be caused by reduced white blood cells
• Reduction in the number of all types of blood cells
• Chest pain or sore throat
• Indigestion, abdominal discomfort
• Nasal congestion
• Back pain, bone pain
• Reduced muscle coordination or difficulty reading, increased or decreased tear production, loss of eyelashes
• Changes in heart rate or rhythm, heart failure
• Decreased or increased 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 side effects (may affect up to 1 in 100 people):

• Weight gain, increased blood lactate dehydrogenase, decreased kidney function, increased blood sugar, increased blood phosphorus
• Decreased or absent reflexes, involuntary movements, neuralgia, fainting, dizziness upon standing, tremor, facial nerve paralysis
• Eye irritation, eye pain, eye redness, eye itching, double vision, reduced visual acuity or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular edema)
• Ear pain, ringing in the ears
• Cough with mucus, shortness of breath when walking or climbing stairs, runny or dry nose, decreased breath sounds, fluid in the lungs, hoarseness, blood clot in the lung, dry throat
• Flatulence (intestinal gas), stomach cramps, gum pain, rectal bleeding
• Painful urination, frequent urination, blood in the urine, urinary incontinence
• Pain in fingernails, discomfort in fingernails, loss of fingernails, hives, skin pain, photosensitivity reaction, pigmentation disorders, increased sweating, night sweats, white spots on the skin, skin lesions, facial swelling
• Decreased blood phosphorus, fluid retention, low albumin levels in the blood, increased thirst, decreased blood calcium, low blood sugar, low blood sodium
• Nasal pain and swelling, skin infections, catheter-related infection
• Bruising
• Pain at the site of the tumour, tumour necrosis
• Decreased blood pressure when standing up, cold sensation in hands and feet
• Difficulty walking, swelling
• Allergic reaction
• Decreased liver function, enlarged liver
• Breast pain
• Restlessness
• Small areas of bleeding under the skin due to blood clots
• A condition involving destruction of red blood cells and acute kidney failure

Rare side effects (may affect up to 1 in 1,000 people):

• Skin reaction to another agent or lung inflammation following radiation
• Blood clot formation
• Very slow pulse, heart attack
• Leakage of medicine from the vein
• A disorder of the heart's electrical conduction system (atrioventricular block)

Very rare side effects (may affect up to 1 in 10,000 people):

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

Side effects not known (frequency cannot be determined from available data):

• Hardening/thickening of the skin (scleroderma)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paclitaxel albumina Dr. Reddy’s

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./EXP. The expiry date refers to the last day of that month.
Closed vials: keep the vial in the outer packaging to protect the medicine from light.
This medicine does not require any special storage conditions.
After first reconstitution, the dispersion must be used immediately. If not used immediately, the dispersion can be stored refrigerated (2 °C - 8 °C) for up to 24 hours in the vial kept in the outer packaging which protects the medicine from light.
The reconstituted dispersion in an intravenous infusion bag can 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 infusion bag, when refrigerated and protected from light, is 24 hours. This may be followed by storage in the infusion bag for up to 4 hours at temperatures below 25 °C.
The physician or pharmacist is responsible for the proper disposal of unused Paclitaxel albumina Dr. Reddy’s.

6. Package contents and other information

What Paclitaxel Albumin Dr. Reddy’s contains

• The active substance is paclitaxel.
• Each vial contains 100 mg of paclitaxel bound to albumin formulated as nanoparticles. After reconstitution, each mL of dispersion contains 5 mg of paclitaxel bound to albumin formulated as nanoparticles.
• 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”.

Description of the appearance of Paclitaxel Albumin Dr. Reddy’s and contents of the pack
Paclitaxel Albumin Dr. Reddy’s is a lyophilized powder for infusion, white to yellow in colour.
Paclitaxel Albumin Dr. Reddy’s is available in 50 mL clear glass vials closed with a rubber stopper and sealed with a flip-off cap, containing 100 mg of paclitaxel bound to albumin formulated as nanoparticles.
Each pack contains 1 vial.
Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy
Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories S.R.L.,
313, Splaiul Unirii,
Building H, 1st floor, sector 3,
Bucharest, 030138,
Romania
Dr. Reddy's Laboratories Romania S.R.L.,
Str. Daniel Danielopolu, nr. 30-32, Spațiul
2, Etaj 5, Sectorul 1,
Bucharest, postal code 014134,
Romania
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 under the following names:

Healthcare Professionals
The following information is intended exclusively for physicians and healthcare professionals:
Instructions for use, handling, and disposal
Precautions for preparation and administration
Paclitaxel is a cytotoxic antineoplastic agent; therefore, as with other potentially toxic compounds, certain precautions should be taken when handling Paclitaxel albumin Dr. Reddy’s. Wear gloves, goggles, and protective clothing. If the dispersion comes into contact with the skin, wash the skin immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse thoroughly with copious amounts of water. Paclitaxel albumin Dr. Reddy’s must be prepared and administered only by personnel adequately trained in the handling of cytotoxic agents. Paclitaxel must not be handled by pregnant women.
Due to the risk of extravasation, the infusion site should be closely monitored for signs of infiltration during administration of the medicinal product. Limiting the paclitaxel infusion to 30 minutes, as indicated, reduces the likelihood of infusion-related reactions.

Reconstitution and Administration of the Medicinal Product
Paclitaxel albumin Dr. Reddy’s must be administered under the supervision of a qualified oncologist in specialized units equipped for the administration of cytotoxic agents.

Paclitaxel albumin Dr. Reddy’s is supplied as a sterile lyophilized powder and must be reconstituted before use. After reconstitution, each mL of dispersion contains 5 mg of paclitaxel bound to albumin formulated as nanoparticles. The reconstituted dispersion of Paclitaxel albumin Dr. Reddy’s is administered intravenously using an infusion set equipped with a 15-micron in-line filter.

Reconstitution:
Using a sterile syringe, slowly inject 20 mL of 9 mg/mL (0.9%) sodium chloride solution for infusion into the 100 mg vial of Paclitaxel albumin Dr. Reddy’s over 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 this may cause foaming.
After the addition of the solution is complete, allow the vial to stand undisturbed for at least 5 minutes to ensure complete wetting of the powder. Then gently and slowly rotate and/or invert the vial for at least 2 minutes until the powder is completely redispersed. Avoid foaming. 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 precipitate. Sediment may be observed in the reconstituted dispersion. If precipitates or sediment are visible, gently invert the vial again to ensure complete redispersion before use.

Inspect the dispersion in the vial for the presence of precipitate. Do not administer the reconstituted dispersion if precipitates are observed in the vial.

The exact total volume of the 5 mg/mL dispersion required for the patient must be calculated, and the appropriate amount of reconstituted Paclitaxel albumin Dr. Reddy’s should be transferred into an empty, sterile intravenous infusion bag made of PVC or non-PVC material.

The use of medical devices containing silicone lubricant (e.g., syringes and IV bags) for reconstituting and administering Paclitaxel albumin Dr. Reddy’s may result in the formation of proteinaceous filaments.

Administer Paclitaxel albumin Dr. Reddy’s using an infusion set equipped with a 15-micron filter to prevent administration of these filaments. The use of a 15-micron filter removes the filaments and does not alter the physical or chemical properties of the reconstituted product.
The use of filters with a pore size smaller than 15 microns may cause filter clogging.

No special DEHP-free containers or administration sets are required for the preparation and administration of Paclitaxel albumin Dr. Reddy’s infusions.

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

Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.

Stability
Unopened vials of Paclitaxel albumin Dr. Reddy’s are stable until the date indicated on the packaging, provided the vial is stored in the original outer packaging to protect from light. Freezing and refrigeration do not adversely affect the stability of the medicinal product. This medicinal product does not require any specific storage temperature.

Stability of the reconstituted dispersion in the vial
The medicinal product has been shown to be chemically and physically stable for 24 hours at 2 °C – 8 °C in the original packaging, protected from light.

Stability of the reconstituted dispersion in the infusion bag
The medicinal product has been shown to be chemically and physically stable for 24 hours at 2 °C – 8 °C, followed by up to 4 hours at 25 °C, protected from light.

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

If the product is not used immediately, the responsibility for the duration and conditions of storage during use lies with 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 be followed by up to 4 hours of storage in the infusion bag at temperatures below 25 °C.