Docetaxel 160mg/8ml Inj, 8ml

Docetaxel is an antineoplastic agent that acts by promoting the assembly of microtubules from tubulin dimers and by stabilizing microtubules by preventing depolymerization. This leads to a significant decrease in free tubulin, and results in the inhibition of normal dynamic reorganization of the microtubule network, which is essential for vital interphase and mitotic cellular functions. Docetaxel also inhibits the synthesis of DNA and protein, probably secondary to its effects on microtubules.

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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 production, 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, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Signs of lung or breathing problems: shortness of breath, breathing difficulties, 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 experience blurred vision, loss of vision, or any changes in your eyesight, 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 experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and 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 fast or irregular heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, loss of appetite, or feeling sluggish, contact your doctor right away. 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 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

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

Mouth irritation or mouth sores.
Changes in nail condition.
Changes in taste.
Muscle or joint pain.
Flushing.
Eye redness.
Excessive tearing.
Weight loss.
Menstrual changes.
Constipation, diarrhea, nausea, vomiting, or decreased appetite (these are common side effects, and your doctor can discuss ways to manage them).
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; contact your doctor if severe or persistent).

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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 symptoms you experienced.
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. 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 (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are prescribed other medications in addition to this one, make sure you understand their warnings, benefits, and risks. Discuss any questions or concerns you have about these medications with your doctor.

Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. 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. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions, consult with your doctor.

As this medication may increase your risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu. You may also be more prone to bleeding, so be cautious and avoid injuries. Use a soft toothbrush and an electric razor to minimize the risk of bleeding.

Before receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Although rare, some people taking this medication in combination with other cancer treatments have developed additional cancers, including certain blood cancers and kidney cancer, months to years after treatment. If you have concerns, discuss them with your doctor.

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

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect fertility in men, so discuss this with your doctor if you have concerns. Additionally, this medication may harm an unborn baby, so a pregnancy test will be conducted before you start 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 last dose. Ask your doctor how long to continue using birth control. If you or your partner becomes pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole): May significantly increase docetaxel plasma concentrations, increasing toxicity. Concomitant use should be avoided.
• Live vaccines: Increased risk of severe infection in immunosuppressed patients.

• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, phenobarbital, St. John's Wort): May decrease docetaxel plasma concentrations, potentially reducing efficacy. Avoid concomitant use if possible.
• Dexamethasone (premedication): While required, it is a moderate CYP3A4 inducer. The dosing regimen is designed to mitigate this interaction.
• Other myelosuppressive agents: Increased risk of severe myelosuppression.
• Other hepatotoxic agents: Increased risk of liver toxicity.

• Warfarin: Potential for altered INR, monitor closely.

• Signs of infection (fever, chills, sore throat)
• Signs of hypersensitivity reaction (rash, flushing, dyspnea, hypotension)
• Peripheral neuropathy (numbness, tingling, weakness)
• Fatigue
• Nausea, vomiting, diarrhea
• Oral mucositis
• Nail changes
• Skin reactions (rash, desquamation)
• Fluid retention (swelling, weight gain, shortness of breath)

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 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, breastfeeding is contraindicated during docetaxel therapy 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.

Clinical studies have not identified differences in efficacy between elderly and younger patients. However, elderly patients (≥65 years) may have an increased incidence of certain adverse reactions, including fluid retention, neutropenia, and febrile neutropenia. Close monitoring is warranted.

• Premedication with oral corticosteroids (e.g., dexamethasone) is crucial to minimize hypersensitivity reactions and fluid retention. Ensure patients adhere strictly to the premedication schedule.
• Monitor CBC frequently, especially ANC, as neutropenia is a common and dose-limiting toxicity. Consider G-CSF prophylaxis in high-risk patients or with certain regimens.
• Assess for fluid retention (peripheral edema, weight gain, pleural effusion, ascites) before each cycle. Management may include diuretics or dose adjustment.
• Be vigilant for signs of hypersensitivity reactions, which can occur even with premedication. Have emergency equipment and medications readily available.
• Peripheral neuropathy is a common cumulative toxicity. Monitor for symptoms and consider dose reduction or discontinuation if severe.
• Docetaxel is a vesicant/irritant; administer via a central venous catheter if possible, or ensure proper peripheral IV site and monitor for extravasation.
• Patients should be advised to avoid grapefruit and grapefruit juice due to potential CYP3A4 interaction.

• Other cytotoxic chemotherapy agents (e.g., anthracyclines, platinum compounds, antimetabolites depending on cancer type)
• Targeted therapies (e.g., trastuzumab, pertuzumab, CDK4/6 inhibitors for breast cancer)
• Immunotherapy (e.g., PD-1/PD-L1 inhibitors for NSCLC)
• 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 promptly. 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.