Docetaxel 20mg/2ml Inj, 2ml

Docetaxel is an antineoplastic agent that acts by promoting the assembly of microtubules from tubulin dimers and inhibiting their depolymerization, resulting in the formation of stable, nonfunctional microtubule bundles. This leads to the inhibition of mitotic spindle assembly and subsequent disruption of cell division, ultimately inducing apoptosis in rapidly dividing cancer cells.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, vomit that looks like coffee grounds, 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 abnormal heartbeat.
Abnormal sensations such as burning, numbness, or tingling.
Muscle weakness.

Additional Warnings

If the medication leaks from the vein, it can cause tissue damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication can cause a rare eye condition called cystoid macular edema (CME). You may need regular eye exams while taking this medication. If you experience blurred vision or loss of vision, contact your doctor right away.
Severe bowel problems can occur, which can be life-threatening. If you experience stomach pain with or without fever, tender stomach, or diarrhea, contact your doctor immediately.
Liver problems, including rare cases of death, have been reported. If you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.
Tumor lysis syndrome (TLS), a severe health condition, can occur. If you experience fast or abnormal heartbeat, fainting, trouble urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, or loss of appetite, contact your doctor right away. Discuss ways to prevent TLS with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur. If you experience 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 immediately.

Common Side Effects

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
Menstrual changes
Constipation, diarrhea, nausea, vomiting, and decreased appetite (talk to your doctor about ways to manage these side effects)
Hair loss (usually temporary, but in some cases, hair growth may not return to normal)
Fatigue or weakness (can last from a few days to several weeks)

If any of these side effects bother you, do not improve, or are severe, contact your doctor. This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or 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. Note that you should not breastfeed while taking this medication and for 1 week after your last dose.

Please note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

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 prevent injuries, use a soft toothbrush, and consider using an electric razor.

Before receiving any vaccinations, consult 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 discuss any concerns with your doctor.

Some formulations of this medication may contain albumin, a blood component that can potentially transmit viruses. However, the medication is thoroughly screened, tested, and treated to minimize the risk of infection. If you have questions or 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 this with your doctor if you are trying to conceive. Furthermore, 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 while taking this medication and for a specified period after the final 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) - may significantly increase docetaxel exposure and toxicity.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, phenobarbital, St. John's Wort) - may decrease docetaxel exposure and efficacy.
• Live vaccines - increased risk of infection.
• Other myelosuppressive agents - increased risk of severe myelosuppression.
• Warfarin - potential for altered INR (monitor closely).

• Moderate CYP3A4 inhibitors/inducers - monitor for altered docetaxel efficacy/toxicity.
• Substrates of CYP3A4 (e.g., midazolam, cyclosporine, tacrolimus) - potential for altered metabolism of co-administered drugs.
• Drugs causing fluid retention (e.g., corticosteroids, NSAIDs) - may exacerbate docetaxel-induced fluid retention.
• Neurotoxic agents (e.g., cisplatin, oxaliplatin) - increased risk of peripheral neuropathy.

• Not specifically identified as minor interactions with clinical significance requiring intervention.

• Fever or signs of infection (e.g., chills, sore throat)
• Unusual bleeding or bruising
• Numbness, tingling, or weakness in hands or feet (peripheral neuropathy)
• Swelling in hands, feet, ankles, or face (fluid retention)
• Shortness of breath or difficulty breathing
• Severe skin reactions (rash, peeling)
• Severe diarrhea or mucositis
• Persistent fatigue or weakness
• Signs of allergic reaction during infusion (e.g., rash, itching, flushing, difficulty breathing, chest tightness)

Docetaxel can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the 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, breastfeeding is contraindicated during docetaxel therapy and for at least 1 week after the last dose.

Safety and effectiveness in pediatric patients have not been established. Docetaxel is generally not recommended for use in pediatric populations outside of specific clinical trials.

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

• Premedication with oral corticosteroids (e.g., dexamethasone 8 mg twice daily for 3 days starting 1 day prior to docetaxel infusion) is essential to reduce the incidence and severity of fluid retention and hypersensitivity reactions.
• Monitor CBC frequently, especially neutrophil counts, as myelosuppression (particularly neutropenia) is the dose-limiting toxicity. Nadir typically occurs 5-9 days post-infusion.
• Fluid retention can be significant and cumulative; monitor weight and assess for edema, pleural effusions, or ascites. Premedication helps, but diuretics may be needed.
• Peripheral neuropathy is a common and potentially dose-limiting side effect. Monitor for symptoms and consider dose reduction or discontinuation if severe.
• Hypersensitivity reactions can occur, even with premedication. Have emergency equipment and medications readily available during infusion.
• Docetaxel is a vesicant/irritant; administer via a central venous catheter if possible, or ensure proper peripheral IV access and monitor for extravasation.
• Hepatic impairment significantly affects docetaxel clearance and increases toxicity; dose adjustments or contraindication apply based on LFTs.

• Other chemotherapy agents (e.g., anthracyclines, platinum compounds, antimetabolites, topoisomerase inhibitors) depending on cancer type and stage.
• Targeted therapies (e.g., trastuzumab, pertuzumab, lapatinib for HER2+ breast cancer)
• Immunotherapy (e.g., PD-1/PD-L1 inhibitors)
• Hormonal therapies (e.g., tamoxifen, aromatase inhibitors for hormone-sensitive breast cancer; androgen deprivation therapy for prostate cancer)

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 or take someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.