Drug Safety-related Labeling Changes (SrLC)

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DOCETAXEL (NDA-201525)

(DOCETAXEL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/21/2023 (SUPPL-24)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Based on findings in animals, Docetaxel Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Docetaxel Injection.

Contraception

Females

Based on genetic toxicity findings, advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of Docetaxel Injection.

Males

Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of Docetaxel Injection.

Infertility

Based on findings in animal studies, Docetaxel Injection may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Embryo-Fetal Toxicity

Docetaxel Injection can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 2 months after the last dose of Docetaxel Injection.

Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of Docetaxel Injection [see Warnings and Precautions (5.12), and Use in Specific Populations (8.1, 8.3)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Docetaxel Injection.

• You should use effective birth control (contraception) during treatment with Docetaxel Injection and for 2 months after the last dose.

Males with female partners who are able to become pregnant should use effective birth control during treatment with Docetaxel Injection and for 4 months after the last dose.

…

01/13/2021 (SUPPL-22)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined to align label with the reference listed drug labeling:

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2 [see Warnings and Precautions (5.1)].

Avoid the use of Docetaxel Injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of Docetaxel Injection [see Warnings and Precautions (5.2)].

Do not administer Docetaxel Injection to patients with neutrophil counts of <1500 cells/mm3. Monitor blood counts frequently as neutropenia may be severe and result in infection [see Warnings and Precautions (5.3)].

Do not administer Docetaxel Injection to patients who have a history of severe hypersensitivity reactions to Docetaxel Injection or to other drugs formulated with polysorbate 80 [see Contraindications (4)]. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication.

Hypersensitivity reactions require immediate discontinuation of the Docetaxel Injection infusion and administration of appropriate therapy [see Warnings and Precautions (5.5)].

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

Removal of ‘a 3 day’ prior to dexamethasone premedication.

5 Warnings and Precautions

Additions and/or revisions underlined:

5.3 Hematologic Effects

Perform frequent peripheral blood cell counts on all patients receiving Docetaxel Injection. Do not retreat patients with subsequent cycles of Docetaxel Injection until neutrophils recover to a level >1500 cells/mm3 [see Contraindications (4)]. Avoid retreating patients until platelets recover to a level >100,000 cells/mm3.

Newly added subsection:

5.14 Tumor Lysis Syndrome

Tumor lysis syndrome has been reported with docetaxel [see Adverse Reactions (6.2)]. Patients at risk of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor) should be closely monitored prior to initiating Docetaxel Injection and periodically during treatment. Correction of dehydration and treatment of high uric acid levels are recommended prior to initiation of treatment.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hearing: ototoxicity, hearing disorders and/or hearing loss, including during use with other ototoxic drugs.

Hypersensitivity: anaphylactic shock with fatal outcome in patients who received premedication. Severe hypersensitivity reactions with fatal outcome with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

Metabolism and Nutrition Disorders: electrolyte imbalance, including hyponatremia, hypokalemia, hypomagnesemia, and hypocalcemia. Tumor lysis syndrome, sometimes fatal.

Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or without conjunctivitis, cystoid macular edema (CME). Excessive tearing which may be attributable to lacrimal duct obstruction. Transient visual disturbances (flashes, flashing lights, scotomata), typically occurring during drug infusion and reversible upon discontinuation of the infusion, in association with hypersensitivity reactions.

Musculoskeletal disorder: myositis.

8 Use in Specific Populations

8.6 Hepatic Impairment

Additions and/or revisions underlined:

Avoid docetaxel in patients with bilirubin >ULN and patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN [see Boxed Warning, Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Tumor Lysis Syndrome

Advise patients of the potential risk of tumor lysis syndrome and to immediately report any signs or symptoms associated with this event (nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps) to their healthcare provider. Advise patients of the importance of keeping scheduled appointment for blood work or other laboratory tests and of drinking adequate fluids to avoid dehydration [see Warnings and Precautions (5.14)].

PATIENT INFORMATION

What are the possible side effects of Docetaxel Injection?

Docetaxel Injection may cause serious side effects including death.

Newly added information:

·         Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, or heart problems, and may lead to death. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with Docetaxel Injection. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with Docetaxel Injection, including:

o   nausea

o   vomiting

o   confusion

o   shortness of breath

o   irregular heartbeat

o   dark or cloudy urine

o   reduced amount of urine

o   unusual tiredness

o   muscle cramps

• You may experience side effects of Docetaxel Injection that may impair your ability to drive, use tools, or operate machines. If this happens, do not drive or use any tools or machines before discussing with your healthcare provider.

08/11/2020 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hepatic Impairment

(Additions underlined)

…

Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at  increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death.

Avoid docetaxel in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN [see Warnings and Precautions (5.1)].

For patients with isolated elevations of transaminase >1.5 x ULN, consider docetaxel dose modifications [see Dosage and Administration (2.7)].

Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel therapy.

5.8 Cutaneous Reactions

(Additions underlined)

…

Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with docetaxel treatment.

Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Permanent treatment discontinuation should be considered in patients who experience SCARs.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions underlined)

…

Cutaneous: very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, Scleroderma-like changes (usually preceded by peripheral lymphedema) and severe palmar-plantar erythrodysesthesia. In some cases multiple factors may have contributed to the development of these effects. Severe hand and foot syndrome has been reported. Cases of permanent alopecia have been reported.

…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

(Additions underlined)

What is the most important information I should know about Docetaxel Injection? Docetaxel Injection can cause serious side effects, including death.

…

• Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever.

  …

• Risk of new cancers.  An increase in new (second) cancers has happened in people treated with Docetaxel Injection together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin’s Lymphoma (NHL), and kidney cancer.

  o         Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection.

  Your healthcare provider will check you for new cancers during and after your treatment with Docetaxel Injection.

• Severe skin problems

  Tell your healthcare provider right away if you have any of these signs of a severe skin reaction:

  • redness and swelling of your arms and legs.

  • blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches.

    red, scaly rash all over your body with blisters small red or white bumps under the skin that contain pus (pustules) and fever.

    …

    Before you receive Docetaxel Injection, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to any medicines, including paclitaxel. See "Do not receive Docetaxel Injection if you."

• have a low white blood cell count.

…

Before you receive Docetaxel Injection, tell your healthcare provider about all of your medical conditions, including if you:

…

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Docetaxel Injection.

• You should use effective birth control (contraception) during treatment with Docetaxel Injection and for 6 months after the last dose.

  Males with female partners who are able to become pregnant should use effective birth control during treatment with Docetaxel Injection and for 3 months after the last dose.

  Talk to your healthcare provider if you have questions about birth control options that are right for you.

• are breastfeeding or plan to breastfeed. It is not known if docetaxel passes into your breast milk. Do not breastfeed during treatment with Docetaxel Injection and for 1 week after the last dose. You and your healthcare provider should decide if you will receive Docetaxel Injection or breastfeed.

  …

01/06/2020 (SUPPL-19)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Docetaxel Injection is contraindicated in patients with:

• neutrophil counts of <1500 cells/mm3 [see Warnings and Precautions (5.3)].

5 Warnings and Precautions

Newly added subsection:

5.4 Enterocolitis and Neutropenic Colitis

Enterocolitis and neutropenic colitis (typhlitis) have occurred in patients treated with docetaxel alone and in combination with other chemotherapeutic agents, despite the coadministration of G-CSF. Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications. Enterocolitis and neutropenic enterocolitis may develop at any time, and could lead to death as early as the first day of symptom onset. Monitor patients closely from onset of any symptoms of gastrointestinal toxicity. Inform patients to contact their healthcare provider with new, or

worsening symptoms of gastrointestinal toxicity [see Dosage and Administration (2), Warnings and Precautions (5.3), Adverse Reactions (6.2)].

5.5 Hypersensitivity Reactions

Additions and/or revisions underlined:

… Patients with a history of severe hypersensitivity reactions should not be re-challenged with Docetaxel Injection.

Patients who have previously experienced a hypersensitivity reaction to paclitaxel may develop a hypersensitivity reaction to docetaxel that may include severe or fatal reactions such as anaphylaxis. Monitor patients with a previous history of hypersensitivity to paclitaxel closely during initiation of docetaxel therapy.

Hypersensitivity reactions may occur within a few minutes following initiation of a Docetaxel Injection infusion …

5.7 Second Primary Malignancies replaces ‘Acute Myeloid Leukemia’ subsection title

Newly added information:

Second primary malignancies, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin’s Lymphoma (NHL), and renal cancer, have been reported in patients treated with docetaxel-containing regimens. These adverse reactions may occur several months or years after docetaxel-containing therapy.

Additions and/or revisions underlined:

… In TAC-treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up. Monitor patients for second primary malignancies [see Adverse Reactions (6.1)].

5.12 Embryo-Fetal Toxicity replaces ‘Use in Pregnancy’ subsection title

Additions and/or revisions underlined:

Based on findings from animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to initiating docetaxel. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of Docetaxel Injection. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of Docetaxel Injection [see Use in Specific Populations (8.1, 8.3)].

6 Adverse Reactions

Additions and/or revisions underlined to bulleted line listing:

• Hepatic Impairment [see Boxed Warning, Warnings and Precautions (5.2)]

• Hematologic Effects [see Boxed Warning, Warnings and Precautions (5.3)]

• Enterocolitis and Neutropenic Colitis [see Warnings and Precautions (5.4)]

• Hypersensitivity Reactions [see Boxed Warning, Warnings and Precautions (5.5)]

• Second Primary Malignancies [see Warnings and Precautions (5.7)]

• Alcohol Content [see Warnings and Precautions (5.13)]

  6.1 Clinical Trials Experience

  Following Table 6: Clinically Important Treatment Emergent Adverse Reactions Regardless of Causal Relationship in Patients Receiving Docetaxel in Combination with Doxorubicin and Cyclophosphamide (TAX316), there are significant changes and additions to the following titles (please see label for complete information):

  Fever and Infection

  Gastrointestinal Reactions

  Cardiovascular Reactions

  Adverse reactions during the follow-up period (median follow-up time of 8 years)

  Nervous system disorders

  Skin and subcutaneous tissue disorders

  Reproductive system and breast disorders

  General disorders and administration site conditions

  Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS)

  6.2 Postmarketing Experience

  Additions and/or revisions underlined:

  Body as a whole: diffuse pain, chest pain, radiation recall phenomenon, injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation.

  Cardiovascular: atrial fibrillation, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction. Ventricular arrhythmia including ventricular tachycardia has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide, and may be associated with fatal outcome.

  Gastrointestinal: enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, has been reported with a potential fatal outcome. Abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage …

  Hypersensitivity: rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication. Hypersensitivity reactions with potential fatal outcome have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

  Metabolism and Nutrition Disorders: electrolyte imbalance, including cases of hyponatremia, hypokalemia, hypomagnesemia, and hypocalcemia have been reported.

  Ophthalmologic:

  … These were reversible upon discontinuation of the infusion. Cases of cystoid macular edema (CME) have been reported in patients treated with docetaxel.

  Second primary malignancies: second primary malignancies, including AML, MDS, NHL, and renal cancer, have been reported in patients treated with docetaxel-containing regimens [see Warnings and Precautions (5.7)].

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; additions and/or revisions underlined:

Risk Summary

Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Docetaxel Injection contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations]. In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [see Data]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Docetaxel Injection contains alcohol [see Warnings and Precautions (5.13)]. Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development.

Data

Animal data

Intravenous administration of greater than or equal to 0.3 and 0.03 mg/kg/day docetaxel to pregnant rats and rabbits, respectively, during the period of organogenesis caused an increased incidence of intrauterine mortality, resorptions, reduced fetal weights, and fetal ossification delays. Maternal toxicity was also observed at these doses, which were approximately 0.02 and 0.003 times the daily maximum recommended human dose based on body surface area, respectively.

8.2 Lactation

PLLR conversion; additions and/or revisions underlined:

Risk Summary

There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with docetaxel and for 1 week after the last dose.

8.3 Females and Males of Reproductive Potential

PLLR conversion; newly added subsection:

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Docetaxel injection.

Contraception

Females

Docetaxel can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of docetaxel injection.

Males

Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of docetaxel injection.

Infertility

Based on findings in animal studies, docetaxel may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Extensively changed; please refer to label for complete information:

PATIENT INFORMATION

Additions and/or revisions underlined:

What is the most important information I should know about Docetaxel Injection?

Docetaxel Injection can cause serious side effects, including death.

• Severe allergic reactions are medical emergencies that can happen in people who receive Docetaxel Injection and can lead to death. You may be at higher risk of developing a severe allergic reaction to Docetaxel Injection if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your infusion of Docetaxel Injection.

  Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction …

• Your body may hold too much fluid (severe fluid retention) during treatment with Docetaxel Injection … Tell your doctor healthcare provider or nurse before your Docetaxel Injection treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you. Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath.

  See "What is the most important information I should know about Docetaxel Injection?" for the signs and symptoms of a severe allergic reaction.

  See the end of this Patient Information for a complete list of the ingredients in Docetaxel Injection.

  The most common side effects of Docetaxel Injection include:

• infections

• low white blood cells (help fight infections), low red blood cells (anemia), and low platelets (help blood to clot)

• allergic reactions (See “What is the most important information I should know about Docetaxel Injection?”)

• shortness of breath

• …

03/27/2019 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hypersensitivity Reactions

Newly Added information:

Cross-hypersensitivity between paclitaxel and docetaxel has been reported. This may include more severe reactions such as anaphylactic reactions. These patients should be closely monitored during initiation of docetaxel therapy.

6 Adverse Reactions

Newly added to bulleted line listing:

• Acute Myeloid Leukemia

• Cutaneous Reactions

• Neurologic Reactions

• Eye Disorders

• Asthenia

• Alcohol Intoxication

6.2 Postmarketing Experiences

Additions and/or revisions underlined:

Body as a whole: … injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed.

Cutaneous: … Cases of permanent alopecia have been reported.

Hypersensitivity: … Hypersensitivity reactions have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

• Explain to patients that side effects such as nausea … and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel injection administration.

PATIENT INFORMATION

Additions and/or revisions underlined:

• Severe allergic reactions can happen in people who receive Docetaxel Injection.  If you have had an allergic reaction to the medicine paclitaxel in the past, these reactions may be more severe. Severe allergic reactions are medical emergencies that can lead to death and must be treated right away. Your doctor will monitor you closely for allergic reactions during your infusion of Docetaxel Injection.

Before you receive Docetaxel Injection, tell your doctor about all of your medical conditions, including if you: are allergic to any medicines. See "Do not receive Docetaxel Injection if you."

• have had an allergic reaction to the medicine paclitaxel.

  What are the possible side effects of Docetaxel Injection? Docetaxel Injection may cause serious side effects, including death.

  •           See "What is the most important information I should know about Docetaxel Injection?"

• Neurologic problems. Neurologic problems are common in people who receive Docetaxel Injection but can be severe. Tell your doctor if you have any numbness, tingling, or burning in your hands or feet (peripheral neuropathy) and weakness of your legs, feet, arms, or hands (motor weakness).

The most common side effects of Docetaxel Injection include:

• infections

• low white blood cell, red blood cell, and platelet counts

• hair loss: In some people, permanent hair loss is reported

03/27/2019 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hypersensitivity Reactions

Newly Added information:

Cross-hypersensitivity between paclitaxel and docetaxel has been reported. This may include more severe reactions such as anaphylactic reactions. These patients should be closely monitored during initiation of docetaxel therapy.

6 Adverse Reactions

Newly added to bulleted line listing:

• Acute Myeloid Leukemia

• Cutaneous Reactions

• Neurologic Reactions

• Eye Disorders

• Asthenia

• Alcohol Intoxication

6.2 Postmarketing Experiences

Additions and/or revisions underlined:

Body as a whole: … injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed.

Cutaneous: … Cases of permanent alopecia have been reported.

Hypersensitivity: … Hypersensitivity reactions have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

• Explain to patients that side effects such as nausea … and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel injection administration.

PATIENT INFORMATION

Additions and/or revisions underlined:

• Severe allergic reactions can happen in people who receive Docetaxel Injection.  If you have had an allergic reaction to the medicine paclitaxel in the past, these reactions may be more severe. Severe allergic reactions are medical emergencies that can lead to death and must be treated right away. Your doctor will monitor you closely for allergic reactions during your infusion of Docetaxel Injection.

Before you receive Docetaxel Injection, tell your doctor about all of your medical conditions, including if you: are allergic to any medicines. See "Do not receive Docetaxel Injection if you."

• have had an allergic reaction to the medicine paclitaxel.

  What are the possible side effects of Docetaxel Injection? Docetaxel Injection may cause serious side effects, including death.

  •           See "What is the most important information I should know about Docetaxel Injection?"

• Neurologic problems. Neurologic problems are common in people who receive Docetaxel Injection but can be severe. Tell your doctor if you have any numbness, tingling, or burning in your hands or feet (peripheral neuropathy) and weakness of your legs, feet, arms, or hands (motor weakness).

The most common side effects of Docetaxel Injection include:

• infections

• low white blood cell, red blood cell, and platelet counts

• hair loss: In some people, permanent hair loss is reported

10/21/2016 (SUPPL-12)

6 Adverse Reactions

The most serious adverse reactions from docetaxel are:

Addition of the following:

• Acute Myeloid Leukemia
• Cutaneous Reactions
• Neurological Reactions
• Eye Disorders
• Asthenia
• Alcohol Intoxication

6.1 Clinical Trial Experience

Table 11 - Clinically Important Treatment Emergent Adverse Reactions (Regardless of Relationship) in Patients with SCCHN Receiving Induction Chemotherapy with Docetaxel in Combination with Cisplatin and Fluorouracil Followed by Radiotherapy (TAX323) or Chemoradiotherapy (TAX324) (addition to table heading is underlined)

6.2 Post-Marketing Experiences

Cutaneous: very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions… Severe hand and foot syndrome has been reported. Cases of permanent alopecia have been reported. (addition underlined)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

The following was moved in the section to follow the alcohol content bullet and a phrase was added (underlined). Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.

The most common side effects of Docetaxel Injection include:

• hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed. (addition underlined)