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Adcetris (Generic Brentuximab Vedotin Injection)

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WARNING

Receiving an injection of brentuximab vedotin may make you more likely to experience progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). If you currently have or have ever had an immune system-compromising condition, let your doctor know. If you are using any immune system suppressing drugs, let your doctor and pharmacist know. Call your doctor right away and stop taking brentuximab vedotin injectable if you have any of the following symptoms: a change in vision, difficulty speaking, difficulty walking, loss of coordination, headache, confusion, memory loss, decreased strength or weakness on one side of the body, or changes in mood or customary behaviour.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the injection of brentuximab vedotin, your doctor might prescribe specific tests.

Ask your doctor about the dangers of receiving an injection of brentuximab vedotin.

Why is this medication prescribed?

Adult patients with specific forms of Hodgkin lymphoma are treated with a chemotherapeutic drug called bretuximab vedotin injection, either alone or in combination with other drugs. Additionally, it is used to treat adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL), certain types of peripheral T-cell lymphomas (PTCL; a type of non-Hodgkin lymphoma), and certain types of anaplastic large cell lymphomas (sALCL) either alone or in combination with other chemotherapy. As the initial therapy for Hodgkin lymphoma, paediatric patients 2 years of age and older get chemotherapy in addition to the drug brentuximab vedotin. An injection of brentuximab vedotin belongs to a group of drugs known as antibody-drug conjugates. It eliminates cancer cells to work.

How should this medicine be used?

The injection of brentuximab vedotin is administered intravenously (into a vein) over the course of 30 minutes by a doctor or nurse at a clinic or hospital. For as long as your doctor advises you to get treatment, brentuximab vedotin is typically injected once every three weeks to treat Hodgkin’s lymphoma, sALCL, or PTCL. For as long as your doctor advises you to receive treatment, brentuximab vedotin is typically injected once every two weeks when it is used in conjunction with chemotherapy to treat Hodgkin lymphoma as a first line treatment.

Serious adverse reactions to the medication, which typically happen during the infusion or within 24 hours of getting a dosage, are possible with the injection of brentuximab vedotin. If you have experienced an adverse reaction while receiving treatment, you can be given specific drugs prior to your infusion to prevent such reaction. While you are receiving brentuximab vedotin, your doctor will keep a close eye on you. Inform your doctor right once if you suffer any of the following symptoms: fever, chills, rash, hives, itching, or breathing difficulties.

If you have specific adverse effects, your doctor may need to postpone your treatment, change your dose, or discontinue it altogether. Tell your doctor how you are feeling while receiving an injection of brentuximab vedotin.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving brentuximab vedotin injection,

  • If you have an allergy to brentuximab vedotin, any other drugs, or any of the ingredients in brentuximab vedotin injection, tell your doctor and pharmacist right away. Request a list of the components from your pharmacist.
  • If you are receiving bleomycin, let your doctor know. If you are taking this medicine, your doctor will probably advise you not to use brentuximab vedotin injection.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention any of the following: rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), clarithromycin (Biaxin, in PrevPac), indinavir (Crixivan), itraconazole (Sporanox), ketoconazole, nefazodone, nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have previously had liver or kidney disease, let your doctor know.
  • If you are pregnant or want to become pregnant, let your doctor know. You must perform a pregnancy test before commencing treatment if you are a woman who is able to get pregnant, and you must use reliable birth control both during therapy and for six months after your last dose. You must use reliable birth control during treatment and for six months following your last dosage if you are a male with a female partner who is pregnant or could become pregnant. Consult your doctor about your options for birth control. Call your doctor right away if you or your partner become pregnant while getting a brentuximab vedotin injectable. Injection of brentuximab vedotin may be harmful to the foetus.
  • Inform your doctor if you are nursing a child. If you are given an injection of brentuximab vedotin, you shouldn’t breastfeed.
  • You should be aware that this drug may reduce male fertility. Ask your doctor about the dangers of receiving an injection of brentuximab vedotin.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The injection of brentuximab vedotin may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Oral sores
  • Diminished appetite
  • Loss of weight
  • Tiredness
  • Dizziness
  • Weakness
  • Having trouble falling or staying asleep
  • Anxiety
  • Arid skin
  • Hair fall
  • Sweats at night
  • Back, arm, leg, joint, bone, or muscle pain
  • Spasms of muscles

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Uncommon bruising or bleeding
  • Hands, arms, feet, or legs that are numb, burning, or tingly
  • Muscle tremor
  • Blistered or flaky skin
  • Hives
  • Rash
  • Itching
  • Nausea
  • Vomiting
  • Diarrhea
  • Coughing or breathlessness
  • Less urinations
  • Hands, foot, ankles, or lower legs swelling
  • Frequent, painful, or challenging urinating
  • Fever, chills, cough, or other infection-related symptoms
  • Ongoing stomach ache that occasionally radiates to the back
  • Light skin
  • The skin or eyes turning yellow
  • Discomfort or pain in the right upper abdominal region
  • Dark faeces
  • Bowel motions that have a clay colour
  • Abdominal pain
  • Uncommon bruising or bleeding
  • Seats that are dark and tarry
  • Blood in the faeces, red

Other negative effects of the injection of brentuximab vedotin are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Fever, chills, cough, or other infection-related symptoms

What other information should I know?

Ask your pharmacist any inquiries you may have regarding the injection of brentuximab vedotin.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Adcetris®
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