1000 mg concentrate for solution for infusion
obinutuzumab

1. What Gazyvaro is and what it is used for

What Gazyvaro is

Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called ‘monoclonal antibodies. Antibodies work by binding to specific targets in your body.

What Gazyvaro is used for

Gazyvaro can be used in adults to treat two different types of cancer

  • Chronic lymphocytic leukemia (also called “CLL”)
    • Gazyvaro is used in patients who have not previously received any treatment for CLL and who have other conditions that make it unlikely that they could handle a full dose of another medicine used to treat KLL called fludarabine.
    • Gazyvaro is used in combination with another anticancer medicine called chlorambucil.
  • Follicular lymphoma (also called “FL”)
    • Gazyvaro is used in patients who have not received any treatment for FL
    • Gazyvaro is used in patients who have received at least one previous treatment with a drug called rituximab and whose FL has returned or worsened during or after this treatment.
    • At the start of treatment with FL, Gazyvaro is used with other anticancer medicines.
    • Gazyvaro can be used as the only medicine for up to 2 years as a “maintenance treatment”.

How Gazyvaro works

  • KLL and FL are types of cancer that affect white blood cells called “B lymphocytes”. The affected “B lymphocytes” divide too quickly and live too long. Gazyvaro binds to the surface of the B lymphocytes , leading to their death.
  • When Gazyvaro is given to patients with CLL or FL together with other anticancer medicines, it takes time for their disease to worsen.

2. What you need to know before you are treated with Gazyvaro

You should not be treated with Gazyvaro if:

  • you are allergic to obinutuzumab or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before giving Gazyvaro.

Warnings and cautions

Talk to a doctor or nurse before you are treated with Gazyvaro if:

  • you have an infection , or have previously had an infection that was prolonged or constantly coming back
  • have you ever taken, or received, medicines that affect the immune system (such as chemotherapy drugs or immunosuppressants)
  • you are taking any medicine for high blood pressure or medicines that are used to thin your blood – your doctor may need to change how you take these
  • you have ever had heart problems
  • you have ever had problems with the brain (such as memory problems, movement problems or sensations in the body, problems with vision)
  • you have ever had breathing or lung problems
  • you have ever had hepatitis B, a type of liver disease
  • you should undergo a vaccination or know that you may need one in the near future.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Gazyvaro.

Be aware of the following side effects are

Gazyvaro can cause serious side effects that you must tell your doctor or nurse immediately. These include:

Infusion-related reactions

  • Tell your doctor or nurse immediately if you get any of the infusion-related reactions listed at the beginning of section 4. Infusion-related reactions may occur during infusion one up to 24 hours after infusion one.
  • If you get an infusion-related reaction, you may need further treatment or your infusion may need to be slowed down or stopped. When the reactions disappear, or improve, the infusion can be continued. These reactions are more likely to occur during the first infusion . Your doctor may decide to stop using Gazyvaro if you get a strong infusion reaction.
  • Before each infusion of Gazyvaro, you will be given medicines to help reduce any infusion-related reactions or “tumor light syndrome”. Tumor light syndrome is a potentially life-threatening complication caused by chemical changes in the blood that occur due to the breakdown of dying cancer cells (see section 3).

Progressive multifocal leukoencephalopathy (also called “PML”)

  • PML is a very rare and life-threatening brain infection that has been reported in very few patients treated with Gazyvaro.
  • Tell your doctor or nurse immediately if you have memory loss, difficulty speaking, difficulty walking or problems with your vision.
  • If you have had any of these symptoms before treatment with Gazyvaro, tell your doctor immediately if you notice any changes in them. You may need medical treatment.

Infection is

  • Tell your doctor or nurse immediately if you get any signs of infection after your treatment with Gazyvaro (see “Infections” in section 4).

Children and young people

Do not give Gazyvaro to children or adolescents under 18 years of age, as there is no information on the use of Gazyvaro in these age groups.

Other medicines and Gazyvaro

Tell your doctor or nurse if you have recently taken or might take any other medicines. This includes over-the-counter and herbal medicines.

Pregnancy

  • Tell your doctor or nurse if you are pregnant, think you may be pregnant or are planning to have a baby. They will help you weigh the benefits of continuing to be treated with Gazyvaro against the risk to your child.
  • If you become pregnant during treatment with Gazyvaro, tell your doctor or nurse as soon as possible. This is because treatment with Gazyvaro can affect your or your child’s health.

Breast-feeding

  • Do not breast-feed during treatment with Gazyvaro or for 18 months after stopping treatment with Gazyvaro, as small amounts of the medicine may pass into breast milk.

Contraceptive

  • Use an effective method of contraception while you are being treated with Gazyvaro.
  • Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.

Driving and using machines

Gazyvaro is unlikely to affect your ability to drive, cycle, or use any tools or machines. However, if you get an infusion-related reaction (see section 4), do not drive, cycle or use tools or machines until the reaction has disappeared.

3. How Gazyvaro is given

How Gazyvaro is given

Gazyvaro is given under the supervision of a doctor who has experience in the treatment. It is given into a vein as a drip ( intravenous infusion ) over several hours.

Gazyvaro treatment

Chronic lymphocytic leukemia

  • You will be given 6 cycles of treatment with Gazyvaro in combination with another anticancer medicine called chlorambucil. Each cycle is 28 days long.
  • On day 1 of your first cycle, you will receive a portion of your first Gazyvaro dose of 100 milligrams (mg) very slowly and your doctor / nurse will monitor you closely for infusion-related reactions.
  • If you do not get an infusion-related reaction after the first small dose of your first dose , you can receive the rest of your first dose (900 mg) on ​​the same day.
  • If you get an infusion-related reaction after the first small part of your first dose , you will receive the rest of your first dose on day 2.

A typical treatment schedule is shown below.

Treatment cycle 1 – will include three doses of Gazyvaro during the 28 days:

  • Day 1 – part of your first dose (100 mg)
  • Day 2 or day 1 (continued) – remaining part of the first dose (900 mg)
  • Day 8 – full dose (1000 mg)
  • Day 15 – full dose (1000 mg)

Treatment cycles 2, 3, 4, 5, and 6 – there will only be one dose of Gazyvaro during the 28 days:

  • Day 1 – full dose (1000 mg)

Follicular lymphoma

  • You will be given 6 or 8 cycles of treatment with Gazyvaro in combination with other anticancer medicines – each cycle lasts for 28 or 21 days depending on the other medicines given with Gazyvaro.
  • This initial phase is followed by a “maintenance phase” – during this time you will be given Gazyvaro every two months for up to 2 years as long as your illness does not worsen. Depending on your disease status, your doctor will decide after the initial treatment cycles whether to receive treatment during the maintenance phase.
  • A typical treatment schedule is shown below.

Initial phase

Treatment cycle 1 – it includes three doses of Gazyvaro during the 28 or 21 days, depending on which another medicine is given with Gazyvaro:

  • Day 1 – full dose (1000 mg)
  • Day 8 – full dose (1000 mg)
  • Day 15 – full dose (1000 mg)

Treatment cycle 2-6 or 2-8 – there will only be one dose of Gazyvaro during the 28 or 21 days, depending on which another medicine is given with Gazyvaro:

  • Day 1 – full dose (1000 mg)

Maintenance phase

  • Full dose (1000 mg) once every two months for up to 2 years as long as your disease does not worsen

Medicines are given before each infusion

Before each infusion of Gazyvaro, you will be given medicines that reduce the risk of infusion-related reactions or tumor lysis syndrome. These can be the following:

  • liquid
  • drugs to lower fever
  • analgesics ( analgesics )
  • drugs to reduce inflammation ( cortisone )
  • medicines to reduce an allergic reaction ( antihistamines )
  • drugs to prevent tumor lysis syndrome (such as allopurinol)

If you miss a treatment session with Gazyvaro

Book a new appointment as soon as possible if you miss a treatment, as it is important to follow the dosing schedule for this medicine to be as effective as possible.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:

Serious side effects are

Infusion-related reactions

Tell your doctor or nurse immediately if you get any of the following symptoms during your infusion or up to 24 hours after your infusion.

Most commonly reported:

  • nausea
  • fatigue
  • dizziness
  • headache
  • diarrhea
  • fever, flushing or chills
  • vomiting
  • respiratory distress
  • low or high blood pressure
  • palpitation
  • chest discomfort

Uncommonly reported:

  • irregular heartbeats
  • swelling of the throat or respiratory tract
  • wheezing, difficulty breathing, tightness in the chest or throat irritation

If you get any of the above, tell your doctor or nurse immediately.

Progressive multifocal leukoencephalopathy

PML is a very unusual and life-threatening brain infection that has been reported with Gazyvaro.

Tell your doctor or nurse immediately if you have any

  • memory loss
  • difficulty speaking
  • difficulty walking
  • problem with your vision

If you have had any of these symptoms before treatment with Gazyvaro, tell your doctor immediately if you notice any changes in them. You may need medical treatment.

Infection is

You may be more likely to get an infection during and after treatment with Gazyvaro. These are often colds, but there have been cases of more serious infections. A liver disease called “hepatitis B” has also been reported to recur in patients with a history of hepatitis B.

Contact your doctor or nurse immediately if you get any symptoms of infection during and after your Gazyvara treatment. These include:

  • fever
  • cough
  • chest pain
  • fatigue
  • painful rash
  • sore throat
  • burning sensation when urinating
  • feeling of weakness or general feeling of illness.

If you have had a recurrent or chronic infection before treatment with Gazyvaro, tell your doctor.

Other side effects are

Tell your doctor or nurse if you notice any of the following side effects:

Very common (may affect more than 1 user in 10)

  • fever
  • lung infection
  • headache
  • joint pain, back pain
  • feeling weak
  • feeling tired
  • pain in arms and legs
  • diarrhea, constipation
  • insomnia
  • hair loss, itching
  • urinary tract infection, rhinitis and sore throat, shingles
  • changes in blood samples:
    • anemia (low red blood cell count )
    • low number of all types of white blood cells (total)
    • low number of neutrophils (a type of white blood cell )
    • low platelet count (a type of blood cell that helps your blood clot)
  • upper respiratory tract infection ( infection of the nose, throat, larynx and sinuses), cough

Common (may affect up to 1 in 10 people)

  • cold sores
  • depression, anxiety
  • influenza
  • weight gain
  • runny nose or nasal congestion
  • eczema
  • pain in the mouth or throat
  • musculoskeletal pain in the chest
  • skin cancer ( squamous cell carcinoma , basal cell carcinoma)
  • skeletal pain
  • irregular heartbeat ( atrial fibrillation )
  • problems urinating, urinary incontinence
  • high blood pressure
  • digestive problems (eg heartburn), hemorrhoids
  • changes in blood samples:
    • low number of lymphocytes (a type of white blood cell ), fever associated with low levels of neutrophils (a type of white blood cell )
    • increase in potassium , phosphate or uric acid – which can cause kidney problems (part of tumor lysis syndrome)
    • reduction of potassium

Uncommon (may affect up to 1 in 100 people)

  • A hole in the stomach or intestines ( gastrointestinal perforation , especially in cases where the cancer affects the gastrointestinal tract)

Tell your doctor or nurse if you notice any of the side effects listed above.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gazyvaro

Gazyvaro will be stored by healthcare professionals in hospitals or clinics. The storage instructions are as follows:

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
  • Store in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will discard any medicines that are no longer in use. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is obinutuzumab: 1000 mg / 40 ml per vial corresponding to a concentration of 25 mg / ml before dilution.
  • The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections.

What the medicine looks like and contents of the pack

Gazyvaro is a concentrate for infusion solution for infusion. It is a colorless to slightly brownish liquid. Gazyvaro is available in a pack of 1 glass vial.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Wyhlen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNV Roche SATel: +32 (0) 2 525 82 11 LithuaniaUAB “Roche Lietuva”Tel: +370 5 2546799
BulgariaRosh BULGARIA LOODETel: +359 2 818 44 44 Luxembourg / Luxemburg(See / See Belgium / Belgium)
Czech RepublicRoche sroTel: +420 – 2 20382111 HungaryRoche (Hungary) Kft.Tel: +36 – 23 446 800
DenmarkRoche a / sTel: +45 – 36 39 99 99 Malta(See Ireland)
GermanyRoche Pharma AGTel: +49 (0) 7624 140 The NetherlandsRoche Nederland BVTel: +31 (0) 348 438050
EestiRoche Eesti OÜTel: + 372 – 6 177 380 NorwayRoche Norge ASTel: +47 – 22 78 90 00
GreeceRoche (Hellas) AE:Ηλ: +30 210 61 66 100 AustriaRoche Austria GmbHTel: +43 (0) 1 27739
SpainRoche Farma SATel: +34 – 91 324 81 00 PolandRoche Polska Sp.z ooTel: +48 – 22 345 18 88
FranceRocheTel: +33 (0) 1 47 61 40 00 PortugalRoche Pharmacêutica Chemica, LdaTel: +351 – 21 425 70 00
CroatiaRoche dooTel: + 385 1 47 22 333 RomaniaRoche România SRLTel: +40 21 206 47 01
IrelandRoche Products (Ireland) Ltd.Tel: +353 (0) 1 469 0700 SloveniaRoche pharmacevtska družba dooTel: +386 – 1 360 26 00
IcelandRoche a / sc / o Icepharma hfPhone: +354 540 8000 Slovak RepublicRoche Slovensko, sroTel: +421 – 2 52638201
ItalyRoche SpATel: +39 – 039 2471 Finland / FinlandRoche OyPuh / Tel: +358 (0) 10 554 500
ΎπροςΓ.Α.Σταμάτης & Σια Λτδ.:Ηλ: +357 – 22 76 62 76 SwedenRoche ABTel: +46 (0) 8 726 1200
LatviaRoche Latvija SIATel: +371 – 6 7039831 United KingdomRoche Products Ltd.Tel: +44 (0) 1707 366000

Muhammad Nadeem

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