Pronunciation:

SARS-COV-2 (COVID-19), VAX-een, AD-e-noe-vye-rus (JAN-sen)

Warnings:

Thrombosis with Thrombocytopenia SyndromeThe Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening.TTS may involve thrombosis at unusual locations for a thrombus (ie, cerebral vein, visceral artery or vein, extremity artery, central artery or vein) or in an extremity vein or pulmonary artery.Among reported cases of TTS following administration of the Janssen COVID-19 Vaccine, symptoms began approximately one to two weeks after vaccination.Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention for shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination.The clinical course of TTS following administration of the Janssen COVID-19 Vaccine shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS, the use of heparin may be harmful and alternative treatments may be needed.Do not administer the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine .

Uses of This Medicine:

SARS-CoV-2 vaccine (adenovirus 26 vector) is under investigation as an active immunization against COVID-19 caused by the SARS-CoV-2 virus in patients 18 years of age and older. SARS-CoV-2 (COVID-19) vaccine is used to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Janssen COVID-19 vaccine is used in patients for whom other authorized or approved COVID-19 vaccines are not accessible or appropriate, or in patients who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine.

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of SARS-CoV-2 (COVID-19) vaccine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of SARS-CoV-2 (COVID-19) vaccine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Rituximab
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune disorder (eg, immune thrombocytopenia), history of or
• Bleeding problem—Use with caution. May make this condition worse.

• Blood clotting problem (eg, thrombosis with thrombocytopenia) after receiving this vaccine or another COVID-19 vaccine (eg, AstraZeneca COVID-19 vaccine), history of—Should not be used in patients with this condition.

• Immune system problems—This condition may decrease the useful effects of the vaccine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

Primary vaccination: This vaccine is given as a single dose.

Booster dose: You may be given a single booster dose of Janssen COVID-19 vaccine at least 2 months after your primary vaccination with this vaccine. You may also receive a single booster dose of this vaccine after your primary vaccination with another authorized or approved COVID-19 vaccine (eg, Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine). It is usually given to patients 18 years of age and older.

This vaccine comes with a Fact Sheet for Recipients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check you closely for any problems that may be caused by this vaccine. Blood tests may be needed to check for unwanted effects. Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Check with your doctor right away if you have blurred vision, chest pain, headache, stomach pain, swelling of your leg, trouble breathing, pinpoint red spots on skin, or unusual bleeding or bruising. These may be symptoms of a serious blood clotting problem called thrombosis with thrombocytopenia syndrome (TTS).

This vaccine may increase the risk for autoimmune problems, including immune thrombocytopenia. Check with your doctor right away if you have black, tarry stools, bleeding gums, blood in the urine or stools, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual tiredness or weakness, or unusual bleeding or bruising during the 42 days after you receive the vaccine.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This vaccine may increase the risk for nervous system problems, including Guillain-Barré syndrome. Check with your doctor right away if you have sudden numbness and weakness in the arms and legs or inability to move the arms and legs during the 42 days after you receive the vaccine.

Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease. It is very important that you take precautions to reduce the risk of COVID-19.

Tell your doctor if you have received another SARS-CoV-2 (COVID-19) vaccine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Difficulty in moving

fever

headache

joint pain or swelling

muscle aches, cramping, pains, or stiffness

nausea

unusual tiredness or weakness

Incidence not known

Anxiety

black, tarry stools

bleeding gums

blood in the urine or stool

bloody nose

blue or pale skin

blurred vision

chest pain or discomfort

chills

confusion

continuing ringing or buzzing or other unexplained noise in the ears

cough

dizziness or lightheadedness

fainting

fast heartbeat

hearing loss

heavier menstrual periods

hives or welts, itching, skin rash

inability to move the arms and legs

numbness, weakness, or tingling in the arms or legs

pain, redness, or swelling in the arm or leg

pinpoint red spots on the skin

redness of the skin

seizures

slurred speech

stomach pain

sudden, severe weakness or numbness in the arm or leg

sudden loss of coordination

trouble breathing

unusual bleeding or bruising

vision changes

vomiting blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Pain, redness, or swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.