Docetaxel 20mg/ml Inj, 1ml

Docetaxel is an antineoplastic agent that acts by promoting the assembly of microtubules from tubulin dimers and inhibiting their depolymerization, resulting in the stabilization of microtubules. This leads to a significant decrease in free tubulin, and the formation of non-functional microtubule bundles and abnormal mitotic structures. This disruption of the mitotic spindle prevents cell division, ultimately leading to cell cycle arrest at the G2/M phase and induction of apoptosis.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding.
Signs of lung or breathing problems: shortness of breath, trouble breathing, cough, or fever.
Dizziness or fainting.
Fast or irregular heartbeat.
Abnormal sensations such as burning, numbness, or tingling.
Muscle weakness.

Additional Important Warnings

This medication can cause tissue damage if it leaks from the vein. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may cause a condition called cystoid macular edema (CME). You may need regular eye exams while taking this medication. If you notice any changes in your vision, such as blurred vision or loss of vision, contact your doctor right away.
This medication can cause severe bowel problems, which can be life-threatening. If you experience stomach pain (with or without fever), tender stomach, or diarrhea, contact your doctor immediately.
Rarely, this medication can cause liver problems, which can be fatal. If you notice signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.
This medication can cause a condition called tumor lysis syndrome (TLS), which can be life-threatening. If you experience a fast or irregular heartbeat, fainting, trouble urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite, contact your doctor immediately. Your doctor can discuss ways to help prevent TLS.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur with this medication. If you notice signs such as red, swollen, blistered, or peeling skin, skin irritation (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes, seek medical help right away.

Other Possible Side Effects

Not everyone experiences side effects, and many people have only minor or no side effects. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or don't go away:

Mouth irritation or mouth sores.
Changes in nail color or texture.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Changes in menstrual cycle.
Constipation, diarrhea, nausea, vomiting, or decreased appetite (common side effects; talk to your doctor about ways to manage them).
Hair loss (usually temporary, but in some cases, hair growth may not return to normal).
Fatigue or weakness (may last from a few days to several weeks; contact your doctor if severe or persistent).

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.
* If you are breastfeeding or plan to breastfeed. Please note that you should not breastfeed while taking this medication and for 1 week after your last dose.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. You must verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking other medications, be aware of their warnings, benefits, and risks, and discuss any questions or concerns with your doctor.

To ensure your safety, avoid driving and other activities that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication contains alcohol, which may cause feelings of intoxication during and after treatment. If you experience confusion, dizziness, stumbling, or excessive sleepiness during or within 1 to 2 hours after treatment, notify your doctor. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions.

As this medication may increase your risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu. You may also be more prone to bleeding, so exercise caution to avoid injury, use a soft toothbrush, and consider using an electric razor.

Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Although rare, there is a possibility of developing other types of cancer, including certain blood cancers and kidney cancer, when using this medication in combination with other cancer treatments. This risk may occur months to years after treatment, so it is essential to discuss any concerns with your doctor.

Some formulations of this medication may contain albumin, a component of blood, which can potentially transmit viruses. However, the medication is thoroughly screened, tested, and treated to minimize the risk of infection. If you have concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility, so discuss any concerns with your doctor. Additionally, this medication can harm an unborn baby, so a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.

If you or your partner may become pregnant, it is crucial to use birth control during treatment and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you or your partner becomes pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit juice) - significantly increase docetaxel exposure and toxicity.
• Live vaccines - risk of severe infection in immunosuppressed patients.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, phenobarbital, St. John's Wort) - may decrease docetaxel exposure and efficacy.
• Other myelosuppressive agents - increased risk of severe myelosuppression.
• Drugs causing fluid retention (e.g., corticosteroids, NSAIDs) - may exacerbate docetaxel-induced fluid retention.

• Not specifically identified as minor, but general caution with drugs metabolized by or affecting CYP3A4.

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Swelling in hands, feet, or ankles
• Shortness of breath, cough
• Numbness, tingling, or weakness in hands or feet
• Severe allergic reactions (rash, hives, difficulty breathing, flushing)
• Severe fatigue
• Nausea, vomiting, diarrhea
• Mouth sores
• Changes in vision or eye pain

Docetaxel can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

It is not known whether docetaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with docetaxel and for 1 week after the last dose.

Safety and effectiveness in pediatric patients have not been established. Docetaxel is not indicated for use in pediatric patients.

No overall differences in effectiveness were observed between elderly (≥65 years) and younger patients. However, elderly patients may be more susceptible to certain adverse reactions, particularly fluid retention, neutropenia, and asthenia. Close monitoring is recommended.

• Premedication with corticosteroids (e.g., dexamethasone 8 mg orally twice daily for 3 days starting 1 day prior to docetaxel administration) is crucial to reduce the incidence and severity of fluid retention and hypersensitivity reactions.
• Monitor CBC frequently, especially during the first cycle, as neutropenia is the dose-limiting toxicity.
• Peripheral neuropathy is cumulative and can be dose-limiting; monitor for symptoms and consider dose reduction or discontinuation if severe.
• Fluid retention can be significant and may require diuretic therapy; monitor weight and signs of edema.
• Docetaxel is formulated with polysorbate 80, which can contribute to hypersensitivity reactions. Ensure appropriate premedication and have emergency equipment readily available.
• Nail changes (onycholysis, discoloration) and alopecia are common and can be distressing for patients.

• Other cytotoxic agents (e.g., anthracyclines, platinum compounds, antimetabolites)
• Targeted therapies (e.g., trastuzumab, pertuzumab, CDK4/6 inhibitors for breast cancer)
• Immunotherapy (e.g., PD-1/PD-L1 inhibitors)
• Hormonal therapies (e.g., tamoxifen, aromatase inhibitors for hormone-sensitive cancers)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.