Approved as an Immunotherapy Treatment in Advanced Non–Small Cell Lung Cancer

Approved as an Immunotherapy Treatment in Advanced Non–Small Cell Lung Cancer

LIBTAYO is a prescription medicine used to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC) that has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, OR your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1," and your tumor does not have an abnormal "EGFR," "ALK," or "ROS1" gene.

LIBTAYO may be used as your first treatment option in advanced NSCLC

The binding of PD-1 (programmed death receptor-1) on T cells to PD-L1 (programmed death-ligand 1) on tumor cells inactivates the T cells and keeps them from killing tumor cells in the body. LIBTAYO works by blocking PD-1, to prevent the binding with the PD-L1 cancer cell protein. This causes the T cell to remain active, so it can potentially attack and kill the cancer cell. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death.

LIBTAYO must be prescribed by a doctor. It is given in a hospital or clinic as a 30-minute intravenous (IV) infusion. This means that it enters the body through a vein. Find out if LIBTAYO is the right treatment option for you by visiting

Important Safety Information

What is the most important information I should know about LIBTAYO?

LIBTAYO is a cure that concede possibility treat sure cancers by working accompanying your invulnerable order. LIBTAYO can cause your immune arrangement to attack common tools and tissues in any region of your party and can influence the way they work. These questions can constantly enhance severe or lethal and can bring about obliteration. You can have more than individual of these questions happening at about the same timeThese problems can take place period during situation or even afterwards your situation has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

  • Lung problems: cough, need of breath, or box for storage pain
  • Intestinal problems: diarrhea (vague stools) or more repeated bowel movements than typical, stools that are angry, dawdle, sticky or have ancestry or substance released, or harsh stomach-area (tummy) pain or affection
  • Liver problems: yellowing of your skin or the whites of your eyes, harsh revulsion or disgorging, pain on the right side of your stomach field (midriff), dark excretion (tea distorted), or draining or discoloring more easily than usual
  • Hormone gland problems:headache that will not depart or different headaches, eye nervousness to light, eye problems, brisk pulse, raised sweating, extreme exhaustion, pressure gain or burden loss, impression more starving or dry than usual, urinating during the day than common, male hair loss, feeling cold, muscle spasm, your voice gets deeper, vertigo or keeling over, or changes in mood or performance, in the way that curbed sex drive, irascibility, or inattention
  • Kidney problems:  decrease in your amount of excretion, ancestry in your urine, lump of your ankles, or eating disorder
  • Skin problems: rash, itching, skin hot or exfoliating, difficult sores or ulcers in opening or nose, neck, or organs area, frenzy or infirmity-like syndromes, or swollen lymph growth
  • Questions can still happen in different means and tissues. These are not all of the signs and syndromes of immune whole questions that can occur with something LIBTAYO. Call or see your healthcare wage earner at once for some new or worsening signs or manifestations, that grant permission include: rib cage pain, uneven pulse, shortness of respiration or lump of ankles, disorientation, sleepiness, thought questions, changes in air or behavior, person who looks down on others, balance questions, itchying or numbness of the weaponry or laps, double vision, hazy concept, nervousness to light, eye pain, changes in eyesight, continuous or harsh influence pain or weakness, influence cramps, depressed cardinal blood containers, or discoloring
  • Infusion reactions that can sometimes be severe. Signs and manifestations of infusion responses can contain: nausea, chills or trembling, tingling or rash, flushing, unwillingness to wait of breath or snoring, vertigo, feel inclined passing out, fever, back or narrow connector pain, or first lump
  • Rejection of a transplanted organ.  Your healthcare householder bear tell you what signs and syndromes you endure report and monitor you, contingent upon the type of organ relocate that you have had
  • Problems, containing graft-versus-host affliction (GVHD), in nation the one have received a cartilage essence (stem container) transplant that uses backer stem containers (allogeneic). These problems can be weighty and can bring about death. These difficulties concede possibility take place if you underwent transplantation either before or subsequently being acted accompanying LIBTAYO. Your healthcare provider will monitor you for these difficulties

Obtaining healing treatment at once can help maintain these problems from appropriate more weighty. Your healthcare householder will check you for these problems all the while your situation accompanying LIBTAYO. Your healthcare provider concede possibility treat you accompanying corticosteroid or birth control method replacement cures. Your healthcare wage earner grant permission also need to delay or entirely stop situation accompanying LIBTAYO if you have severe reactions.

Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby
    Females who are able to become pregnant:

–Your healthcare householder will present you a pregnancy test before you start situation

–You concede possibility use an productive method of pregnancy prevention all the while your situation and for at least 4 months afterwards your last prescription of LIBTAYO. Talk accompanying your healthcare provider about pregnancy prevention means that you can use all the while this time

Discern your healthcare wage earner at once if you become pregnant or believe you concede possibility be meaningful during situation accompanying LIBTAYO

are breastfeeding or plan to usually from breast. It is not known if LIBTAYO passes into your conscience milk. Do not give milk all the while treatment and for not completely 4 months following in position or time the last application of LIBTAYO

Tell your healthcare wage earner about all the cures you take, containing prescription and investment in company cures, vitamins, and herbaceous supplements.

The most coarse aftereffects of LIBTAYO contain muscle or cartilage pain, exhaustion, rash, and diarrhea. These are not all the attainable reactions of LIBTAYO. Call your doctor for healing advice about reactions. You concede possibility report aftereffects to FDA at 1-800-FDA-1088. You may again report aftereffects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.
Delight see full Prescribing News, containing Medication Guide.

What is LIBTAYO?

LIBTAYO is a medicine medicine used to treat community accompanying a type of alveolus cancer named non–small container alveolus cancer (NSCLC). LIBTAYO grant permission be secondhand as your first situation when your lung tumor has not spread outside your breast (regionally advanced pleura malignancy) and you cannot have incision or chemotherapy accompanying dissemination, or your pleura cancer has contaminate additional extents of your body (metastatic alveolus tumor), and your cyst tests positive for extreme “PD-L1,” and your Cancer does not have an strange “EGFR,” “ALK,” or “ROS1” gene.

LIBTAYO is a medicine cure used to treat folk with a type of skin malignancy named cutaneous squamous cell abnormal growth in animate being (CSCC) that has spread or cannot be healed by abscission or radiation.

LIBTAYO is a medicine cure used to treat crowd with a type of skin tumor named basic cell abnormal growth in animate being that cannot be detached by medical procedure (locally leading BCC) and have taken situation with a hedgehog road prevention (HHI) or cannot endure treatment accompanying an HHI.

It is secret if LIBTAYO is cautious and effective in youth.