150 mg and 420 mg powder for concentrate for solution for infusion trastuzumab
What Ogivri is and what it is used for
Ogivri contains the active substance trastuzumab, which is a monoclonal antibody . Monoclonal antibodies are attached to specific proteins or antigens . Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 ( HER2 ). HER2 is found in large amounts on the surface of certain cancer cells ( HER2 -positive cancer) and then stimulates cell growth. When Ogivri binds to HER2, the growth of the cancer cells is stopped and it leads to their death.
Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer then:
- You have early breast cancer with high levels of the HER2 protein.
- You have metastatic breast cancer (breast cancer that has spread outside the original tumor ) with high levels of HER2 . Ogivri can be prescribed in combination with the cytotoxic drugs paclitaxel or docetaxel as first-line treatment for metastatic breast cancer, or it can be prescribed as the only treatment for conditions where other treatments have not shown effect. It is also used in combination with medicines called aromatase inhibitors for the treatment of patients with high levels of HER2 and hormone receptor positive metastatic (spread) breast cancer (cancer that is sensitive to the presence of female sex hormone).
- You have metastatic gastric cancer with high levels of HER2, as it is used in combination with capecitabine or 5-fluorouracil and cisplatin.
What you need to know before you get Ogivri
Do not use Ogivri:
- if you are allergic to trastuzumab, murine (mouse) protein , or any of the other ingredients of this medicine (listed in section 6).
- if you have severe breathing problems at rest due to your cancer or if you need oxygen therapy.
Warnings and cautions
Your doctor will closely monitor your treatment.
Control of the heart
Treatment with Ogivri alone or with a taxane can affect the heart, especially if you have previously been treated with an anthracycline (taxanes and anthracyclines are two other types of medicines used to treat cancer). The effects can be moderate to severe and some patients have died. Your heart function will therefore be checked before and during treatment (every three months) and after (up to two to five years) treatment with Ogivri. If you develop signs of heart failure (insufficient pumping of blood from the heart), your heart function may be checked more often (every six to eight weeks). You may then receive treatment for heart failure or you may need to discontinue treatment with Ogivri.
Talk to your doctor, pharmacist, or nurse before receiving Ogivri if:
- you have had heart failure , coronary heart disease, heart valve disease ( wheezing ) or high blood pressure , if you have taken or are currently taking medicines for high blood pressure .
- you have previously received or are currently receiving a medicine called doxorubicin or epirubicin (a medicine used to treat cancer). These medicines (or other anthracyclines ) can damage the heart muscle and increase the risk of heart problems with Ogivri.
- you suffer from shortness of breath, especially if you are treated with a taxane at the same time. Ogivri can cause breathing difficulties, especially when given for the first time. This can be more serious if you are already short of breath. Patients with severe respiratory distress have in very rare cases died in connection with Ogivribe treatment.
- you have previously received any other treatment for cancer.
If you are taking Ogivri with other medicines used to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin, you should also carefully read the package leaflets for these products.
Children and young people
Ogivri is not recommended for anyone under 18 years of age.
Other medicines and Ogivri
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
It can take up to 7 months for Ogivri to be removed from the body. You should therefore tell your doctor, pharmacist, or nurse that you have been treated with Ogivri if you start any new medication within 7 months of stopping treatment.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Pregnancy
- You should use effective contraception during treatment with Ogivri and for at least 7 months after stopping treatment.
- Your doctor will advise you on the disadvantages and benefits of taking Ogivri during pregnancy. In rare cases, a reduction in the amount of (fetal) fluid surrounding the growing fetus in the uterus has been observed in pregnant women treated with trastuzumab. This condition can be harmful to your baby in the womb and has been associated with the lungs not developing fully, resulting in fetal death.
Breast-feeding
Do not breastfeed your baby during treatment with Ogivri and within 7 months after the last dose of Ogivri as this medicine may pass to your baby through breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ogivri may affect your ability to drive or use machines. If you develop symptoms such as dizziness, drowsiness, chills, or fever during treatment, you should not drive or use machines until these symptoms have disappeared.
Ogivri contains sorbitol (E420) and sodium
Free 150 mg powder for concentrate for solution for infusion
This medicine contains 115.2 mg sorbitol in each vial.
Ogivri 420 mg powder for concentrate for solution for infusion
This medicine contains 322.6 mg sorbitol in each vial.
Sorbitol is a source of fructose. If you have hereditary fructose intolerance, a rare, inherited disease, you should not be given this medicine. Patients with hereditary fructose intolerance can not break down fructose, which can cause serious side effects. Talk to your doctor before using this medicine if you have hereditary fructose intolerance, or can no longer eat sweet food or drink without feeling sick, vomiting, or feeling uncomfortable such as bloating, stomach cramps, or diarrhea.
Ogivri contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’
How to get Ogivri
Before starting treatment, your doctor will determine if your tumor is HER2 -positive. Only patients with HER2 -positive cancer (large amounts of HER2 ) will be treated with Ogivri. Ogivri should only be given by a doctor or nurse. Your doctor will prescribe the right dose and treatment regimen for you. The ogivridose depends on your body weight.
The first dose is given over 90 minutes and you will be observed by healthcare professionals while receiving it if you get any side effects. If the first dose is well tolerated, the following dose may be given for 30 minutes (see section 2 under “Warnings and precautions”). The number of infusions that you receive depends on the effect of the treatment you have. Your doctor will discuss this with you.
Ogivri is given as an infusion into a vein ( intravenous infusion, “drip”), this intravenous formulation is not intended for subcutaneous use (under the skin) and should only be given as an intravenous infusion.
In early breast cancer, metastatic breast cancer, and metastatic gastric cancer, Ogivri is given every three weeks. Ogivri can also be given once a week for metastatic breast cancer.
To prevent medication errors, it is important to check the label of the vial to ensure that the medicine is prepared and administered is Ogivri (trastuzumab) and not any other product containing trastuzumab (eg trastuzumab emtansine or trastuzumab deruxtecan).
If you stop using Ogivri
Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time each week or every three weeks (depending on your dosing interval). This helps the drug to work as well as possible.
It can take up to 7 months before Ogivri disappears from the body. Therefore, your doctor may decide to continue to monitor your heart function even after treatment is over.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects can be serious and may involve hospitalization.
During an infusion of Ogivri, chills, fever and other flu-like symptoms may occur. These side effects are very common (may affect more than 1 in 10 people). Other symptoms caused by infusion one are: nausea, vomiting, pain, increased muscle tension and tremors, headache, dizziness, difficulty breathing, high or low blood pressure, altered heart rhythm (palpitations, heart flutter, or irregular heartbeat), swelling of the face and lips and lips. Some of these symptoms may be severe and some patients have died (see section 2 under “Warnings and precautions”).
These effects occur mainly in connection with the first intravenous infusion (drip) and during the first hours after the start of infusion. They are usually temporary. You will be monitored by healthcare professionals during infusion one and for at least six hours after the start of the first infusion one and two hours after the start of the second infusion. If you develop symptoms, healthcare professionals will slow down or discontinue the infusion and they may give you treatment to counteract the side effects. After improvement of the symptoms, the infusion can be continued.
Occasionally, symptoms may occur later than six hours after the start of the infusion. If this happens to you, contact your doctor immediately. Sometimes the symptoms can improve and later worsen.
Serious side effects are
Other side effects may occur at any time during treatment with Ogivri and are not associated with the actual infusion of Ogivri. Tell a doctor or nurse immediately if you notice any of the following side effects :
- Heart problems can sometimes occur during treatment and sometimes after treatment has stopped and can be serious. They include weakening of the heart muscle that can possibly lead to heart failure , inflammation around the heart and altered heart rhythm. This can lead to symptoms such as shortness of breath (including shortness of breath during the night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart flutter or irregular heartbeat) (see section 2. Checking the heart).
Your doctor will check your heart regularly during and after treatment, but you should tell your doctor immediately if you experience any of the above symptoms.
- Tumor light syndrome (group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate in the blood and low levels of calcium in the blood). Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (heart flutter with a faster or slower heartbeat), cramps, vomiting or diarrhea and tingling in the mouth, hands or feet.
If you experience any of the above symptoms after stopping treatment with Ogivri, talk to your doctor and tell your doctor that you have previously been treated with Ogivri.
Very common side effects: may affect more than 1 user in 10
- infection is
- diarrhea
- constipation
- heartburn ( dyspepsia )
- fatigue
- rash
- chest pain
- abdominal pain
- joint pain
- low levels of red blood cells and white blood cells (which help fight infection ) sometimes with fever
- muscle pain
- conjunctivitis (watery eyes with itching, and crusts on the eyelids)
- watery eyes
- nosebleeds
- rinnsnuva
- hair loss
- tremors
- hot flashes
- dizziness
- nail changes
- weight loss
- loss of appetite
- insomnia _ _
- taste changes
- decreased platelet count
- bruises
- numbness or tingling in the fingers and toes, which can sometimes spread to the rest of the arm or leg
- redness , swelling or sores in the mouth and / or throat
- pain, swelling, redness or tingling in the hands and / or feet
- shortness of breath
- headache
- cough
- vomiting
- nausea
Common side effects: may affect up to 1 in 10 people
- allergic reactions
- dry mouth and skin
- throat infection
- dry eyes
- infection you in the bladder and on the skin
- sweating
- feeling of weakness and not feeling well
- inflammation of the chest
- concern
- inflammation of the liver
- Depression
- renal impact
- increased muscle tone or tension (hypertension)
- asthma
- lung infection
- pain in arms and / or legs
- lung impact
- itchy skin rash
- back pain
- drowsiness ( somnolence )
- neck pain
- hemorrhoids (swelling of the blood vessels around the rectum)
- skeletal pain
- itching
- acne
- leg cramps
Uncommon side effects: may affect up to 1 in 100 people
- deafness
- lumpy rash
- hissing / wheezing breathing
- inflammation or scarring of the lungs
Rare side effects: may affect up to 1 in 1,000 people
- jaundice (yellow skin and whites of the eyes)
- anaphylactic reactions (severe rapid allergic reaction with symptoms such as rash, itchy skin, difficulty breathing or feeling dizzy or fainting)
Other side effects that have been reported: occur in an unknown number of users
- abnormal or impaired blood coagulation
- high potassium levels
- swelling or bleeding behind the eyes
- shock (dangerous drop in blood pressure that causes symptoms such as rapid, shallow breathing, cold sweats, rapid and weak heart rate, dizziness, weakness and fainting)
- abnormal heart rhythm
- respiratory distress
- breathing problems
- acute accumulation of fluid in the lungs
- acutely narrower airways
- abnormally low oxygen content in the blood
- difficulty breathing when lying upright
- liver damage
- swelling of the face, lips and neck
- kidney failure
- abnormally little amniotic fluid around the fetus in the womb
- underdeveloped lungs of the fetus in utero
- abnormal development of the kidneys of the fetus in the womb
Some of the side effects you are experiencing may be due to your underlying breast cancer disease. If you are being treated with Ogivri together with cytotoxic drugs, some of the side effects may also be due to the cytotoxic drugs.
How to store Ogivri
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 outer carton and vial label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Infusion solutions should be used immediately after dilution. Do not use Ogivri if you notice particles or discoloration before administration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is trastuzumab. Each vial contains either;
- 150 mg trastuzumab to be dissolved in 7.2 ml of water for injections, or
- 420 mg trastuzumab to be dissolved in 20 ml water for injections.
- The reconstituted solution contains approximately 21 mg / ml trastuzumab.
- The other ingredients are L-histidine hydrochloride, L-histidine, sorbitol (E420 (see section 2 “Ogivri contains sorbitol (E420) and sodium”)), macrogol 3350, hydrochloric acid and sodium hydroxide (for pH adjustment).
What the medicine looks like and contents of the pack
Ogivri is a powder for concentrate for intravenous infusion, a solution provided in a rubber stopper vial containing either 150 mg or 420 mg of trastuzumab. The powder is freeze-dried and white to slightly yellow. Each carton contains 1 vial of powder.
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Limited T / A Mylan Dublin Biologics
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland
Mylan Germany GmbH
Branch release Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352
Germany