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205, Al Qaizi Building, Al Muteena Street, Deira 40192 AE
JollyRX
205, Al Qaizi Building, Al Muteena Street, Deira , AE
+918003633988 https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/606ecab786617735b12707ae/webp/jollyrx-480x480.png" contact@jollyrx.com
61aafabc70f1d0017e0c9550 ADCETRIS 50 MG https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61aaf7eab422e401b7c887c9/webp/adcetris-50mg-brentuximab-injection.jpg

What is Adcetris and how is it used?

Adcetris is a prescription medicine used to treat the symptoms of (conditions). Adcetris may be used alone or with other medications.

Adcetris belongs to a class of drugs called Antineoplastics, Antimicrotubular; Anti-Nectin-4 Monoclonal Antibodies; Antineoplastics, Anti-CD30 Monoclonal Antibodies.

It is not known if Adcetris is safe and effective in children.

What are the possible side effects of Adcetris?

Adcetris may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • dizziness,
  • nausea,
  • chills,
  • itching,
  • difficulty with speech, thought, vision, or muscle movement,
  • numbness,
  • weakness,
  • burning pain,
  • tingly feeling,
  • loss of feeling in your arms or legs,
  • sudden chest pain or pressure,
  • wheezing,
  • dry cough,
  • shortness of breath,
  • pain or burning when you urinate,
  • increased thirst,
  • increased urination,
  • dry mouth,
  • fruity breath odor,
  • vomiting,
  • stomach pain,
  • confusion,
  • unusual drowsiness,
  • fever,
  • tiredness,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • pale skin,
  • cold hands and feet,
  • lightheadedness,
  • muscle cramps,
  • fast or slow heart rate,
  • decreased urination,
  • tingling in your hands and feet or around your mouth,
  • severe pain in your upper stomach spreading to your back,
  • loss of appetite,
  • stomach pain spreading to your upper right side,
  • dark urine,
  • yellowing of the skin or eyes (jaundice),
  • severe constipation,
  • new or worsening stomach pain,
  • bloody or tarry stools,
  • coughing up blood, and
  • vomiting that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Adcetris include:

    • numbness,
    • tingling,
    • fever,
    • low blood cells counts,
    • nausea,
    • vomiting,
  • diarrhea,
  • constipation, and
  • tiredness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adcetris. For more information, ask your doctor or pharmacist.

INDICATIONS

Previously Untreated Stage III Or IV Classical Hodgkin lymphoma (cHL), In Combination With Chemotherapy.

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with chemotherapy.

cHL consolidation

ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

Relapsed cHL

ADCETRIS is indicated for the treatment of adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Relapsed sALCL

ADCETRIS is indicated for the treatment of adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Relapsed pcALCL Or CD30-Expressing MF

ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder in a single-dose vial for reconstitution.

Storage And Handling

ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white preservative-free lyophilized cake or powder in individually-boxed single-dose vials:

NDC (51144-050-01), 50 mg brentuximab vedotin.

Storage

Store vial at 2–8°C (36–46°F) in the original carton to protect from light.

Special Handling

ADCETRIS is an antineoplastic product. Follow special handling and disposal procedures1.

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Infusion Reactions [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Serious Infections and Opportunistic Infections [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity in the Presence of Severe Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Serious Dermatologic Reactions [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Complications [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data below reflect exposure to ADCETRIS in 931 patients with cHL including 662 patients who received ADCETRIS in combination with chemotherapy in a randomized controlled trial, and 269 who received ADCETRIS as monotherapy (167 in a randomized controlled trial and 102 in a single arm trial). Data summarizing ADCETRIS exposure are also provided for 347 patients with T-cell lymphoma, including 223 patients with PTCL who received ADCETRIS in combination with chemotherapy in a randomized, double-blind, controlled trial; 58 patients with sALCL who received ADCETRIS monotherapy in a single-arm trial; and 66 patients with pcALCL or CD30-expressing MF who received ADCETRIS monotherapy in a randomized, controlled trial. ADCETRIS was administered intravenously at a dose of either 1.2 mg/kg every 2 weeks in combination with AVD, 1.8 mg/kg every 3 weeks in combination with CHP, or 1.8 mg/kg every 3 weeks as monotherapy.

The most common adverse reactions (≥20%) with monotherapy were peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.

The most common adverse reactions (≥20%) in combination with AVD were peripheral neuropathy, neutropenia, nausea, constipation, vomiting, fatigue, diarrhea, pyrexia, alopecia, decreased weight, abdominal pain, anemia, and stomatitis.

The most common adverse reactions (≥20%) in combination with CHP were anemia, neutropenia, peripheral neuropathy, lymphopenia, nausea, diarrhea, fatigue or asthenia, mucositis, constipation, alopecia, pyrexia, and vomiting.

Previously Untreated Stage III Or IV Classical Hodgkin Lymphoma (Study 5: ECHELON-1)

ADCETRIS in combination with AVD was evaluated for the treatment of previously untreated patients with Stage III or IV cHL in a randomized, open-label, multicenter clinical trial of 1334 patients. Patients were randomized to receive up to 6 cycles of ADCETRIS + AVD or ABVD on Days 1 and 15 of each 28-day cycle. The recommended starting dose of ADCETRIS was 1.2 mg/kg intravenously over 30 minutes, administered approximately 1 hour after completion of AVD therapy. A total of 1321 patients received at least one dose of study treatment (662 ADCETRIS + AVD, 659 ABVD). The median number of treatment cycles in each study arm was 6 (range, 1-6); 76% of patients on the ADCETRIS + AVD arm received 12 doses of ADCETRIS [see Clinical Studies].

After 75% of patients had started study treatment, the use of prophylactic G-CSF was recommended with the initiation of treatment for all ADCETRIS + AVD treated patients, based on the observed rates of neutropenia and febrile neutropenia [see DOSAGE AND ADMINISTRATION]. Among 579 patients on the ADCETRIS + AVD arm who did not receive G-CSF primary prophylaxis beginning with Cycle 1, 96% experienced neutropenia (21% with Grade 3; 67% with Grade 4), and 21% had febrile neutropenia (14% with Grade 3; 6% with Grade 4). Among 83 patients on the ADCETRIS + AVD arm who received G-CSF primary prophylaxis beginning with Cycle 1, 61% experienced neutropenia (13% with Grade 3; 27% with Grade 4), and 11% experienced febrile neutropenia (8% with Grade 3; 2% with Grade 4).

Serious adverse reactions, regardless of causality, were reported in 43% of ADCETRIS + AVD-treated patients and 27% of ABVD-treated patients. The most common serious adverse reactions in ADCETRIS + AVD-treated patients were febrile neutropenia (17%), pyrexia (7%), neutropenia and pneumonia (3% each).

Adverse reactions that led to dose delays of one or more drugs in more than 5% of ADCETRIS + AVD-treated patients were neutropenia (21%) and febrile neutropenia (8%) [see DOSAGE AND ADMINISTRATION]. Adverse reactions led to treatment discontinuation of one or more drugs in 13% of ADCETRIS + AVD-treated patients. Seven percent of patients treated with ADCETRIS + AVD discontinued due to peripheral neuropathy.

There were 9 on-study deaths among ADCETRIS + AVD-treated patients; 7 were associated with neutropenia, and none of these patients had received G-CSF prior to developing neutropenia.

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ADCETRIS 50 MG

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Description of product

What is Adcetris and how is it used?

Adcetris is a prescription medicine used to treat the symptoms of (conditions). Adcetris may be used alone or with other medications.

Adcetris belongs to a class of drugs called Antineoplastics, Antimicrotubular; Anti-Nectin-4 Monoclonal Antibodies; Antineoplastics, Anti-CD30 Monoclonal Antibodies.

It is not known if Adcetris is safe and effective in children.

What are the possible side effects of Adcetris?

Adcetris may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • dizziness,
  • nausea,
  • chills,
  • itching,
  • difficulty with speech, thought, vision, or muscle movement,
  • numbness,
  • weakness,
  • burning pain,
  • tingly feeling,
  • loss of feeling in your arms or legs,
  • sudden chest pain or pressure,
  • wheezing,
  • dry cough,
  • shortness of breath,
  • pain or burning when you urinate,
  • increased thirst,
  • increased urination,
  • dry mouth,
  • fruity breath odor,
  • vomiting,
  • stomach pain,
  • confusion,
  • unusual drowsiness,
  • fever,
  • tiredness,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • pale skin,
  • cold hands and feet,
  • lightheadedness,
  • muscle cramps,
  • fast or slow heart rate,
  • decreased urination,
  • tingling in your hands and feet or around your mouth,
  • severe pain in your upper stomach spreading to your back,
  • loss of appetite,
  • stomach pain spreading to your upper right side,
  • dark urine,
  • yellowing of the skin or eyes (jaundice),
  • severe constipation,
  • new or worsening stomach pain,
  • bloody or tarry stools,
  • coughing up blood, and
  • vomiting that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Adcetris include:

    • numbness,
    • tingling,
    • fever,
    • low blood cells counts,
    • nausea,
    • vomiting,
  • diarrhea,
  • constipation, and
  • tiredness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adcetris. For more information, ask your doctor or pharmacist.

INDICATIONS

Previously Untreated Stage III Or IV Classical Hodgkin lymphoma (cHL), In Combination With Chemotherapy.

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with chemotherapy.

cHL consolidation

ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

Relapsed cHL

ADCETRIS is indicated for the treatment of adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Relapsed sALCL

ADCETRIS is indicated for the treatment of adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Relapsed pcALCL Or CD30-Expressing MF

ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder in a single-dose vial for reconstitution.

Storage And Handling

ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white preservative-free lyophilized cake or powder in individually-boxed single-dose vials:

NDC (51144-050-01), 50 mg brentuximab vedotin.

Storage

Store vial at 2–8°C (36–46°F) in the original carton to protect from light.

Special Handling

ADCETRIS is an antineoplastic product. Follow special handling and disposal procedures1.

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Infusion Reactions [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Serious Infections and Opportunistic Infections [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity in the Presence of Severe Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Serious Dermatologic Reactions [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Complications [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data below reflect exposure to ADCETRIS in 931 patients with cHL including 662 patients who received ADCETRIS in combination with chemotherapy in a randomized controlled trial, and 269 who received ADCETRIS as monotherapy (167 in a randomized controlled trial and 102 in a single arm trial). Data summarizing ADCETRIS exposure are also provided for 347 patients with T-cell lymphoma, including 223 patients with PTCL who received ADCETRIS in combination with chemotherapy in a randomized, double-blind, controlled trial; 58 patients with sALCL who received ADCETRIS monotherapy in a single-arm trial; and 66 patients with pcALCL or CD30-expressing MF who received ADCETRIS monotherapy in a randomized, controlled trial. ADCETRIS was administered intravenously at a dose of either 1.2 mg/kg every 2 weeks in combination with AVD, 1.8 mg/kg every 3 weeks in combination with CHP, or 1.8 mg/kg every 3 weeks as monotherapy.

The most common adverse reactions (≥20%) with monotherapy were peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.

The most common adverse reactions (≥20%) in combination with AVD were peripheral neuropathy, neutropenia, nausea, constipation, vomiting, fatigue, diarrhea, pyrexia, alopecia, decreased weight, abdominal pain, anemia, and stomatitis.

The most common adverse reactions (≥20%) in combination with CHP were anemia, neutropenia, peripheral neuropathy, lymphopenia, nausea, diarrhea, fatigue or asthenia, mucositis, constipation, alopecia, pyrexia, and vomiting.

Previously Untreated Stage III Or IV Classical Hodgkin Lymphoma (Study 5: ECHELON-1)

ADCETRIS in combination with AVD was evaluated for the treatment of previously untreated patients with Stage III or IV cHL in a randomized, open-label, multicenter clinical trial of 1334 patients. Patients were randomized to receive up to 6 cycles of ADCETRIS + AVD or ABVD on Days 1 and 15 of each 28-day cycle. The recommended starting dose of ADCETRIS was 1.2 mg/kg intravenously over 30 minutes, administered approximately 1 hour after completion of AVD therapy. A total of 1321 patients received at least one dose of study treatment (662 ADCETRIS + AVD, 659 ABVD). The median number of treatment cycles in each study arm was 6 (range, 1-6); 76% of patients on the ADCETRIS + AVD arm received 12 doses of ADCETRIS [see Clinical Studies].

After 75% of patients had started study treatment, the use of prophylactic G-CSF was recommended with the initiation of treatment for all ADCETRIS + AVD treated patients, based on the observed rates of neutropenia and febrile neutropenia [see DOSAGE AND ADMINISTRATION]. Among 579 patients on the ADCETRIS + AVD arm who did not receive G-CSF primary prophylaxis beginning with Cycle 1, 96% experienced neutropenia (21% with Grade 3; 67% with Grade 4), and 21% had febrile neutropenia (14% with Grade 3; 6% with Grade 4). Among 83 patients on the ADCETRIS + AVD arm who received G-CSF primary prophylaxis beginning with Cycle 1, 61% experienced neutropenia (13% with Grade 3; 27% with Grade 4), and 11% experienced febrile neutropenia (8% with Grade 3; 2% with Grade 4).

Serious adverse reactions, regardless of causality, were reported in 43% of ADCETRIS + AVD-treated patients and 27% of ABVD-treated patients. The most common serious adverse reactions in ADCETRIS + AVD-treated patients were febrile neutropenia (17%), pyrexia (7%), neutropenia and pneumonia (3% each).

Adverse reactions that led to dose delays of one or more drugs in more than 5% of ADCETRIS + AVD-treated patients were neutropenia (21%) and febrile neutropenia (8%) [see DOSAGE AND ADMINISTRATION]. Adverse reactions led to treatment discontinuation of one or more drugs in 13% of ADCETRIS + AVD-treated patients. Seven percent of patients treated with ADCETRIS + AVD discontinued due to peripheral neuropathy.

There were 9 on-study deaths among ADCETRIS + AVD-treated patients; 7 were associated with neutropenia, and none of these patients had received G-CSF prior to developing neutropenia.

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